skincancerRx

2022
R Package
skincancerRx is an R package designed to visualize FDA approvals for skin cancer.
Author

David M. Miller, Sophia Z. Shalhout

Published

December 5, 2022

Overview

skincancerRx an R package designed to visualize FDA approvals for skin cancer. The data used in this package was first published as a preprint at themillerlab.io and subsequently accepted at Dermatology Online Journal. In addition, the functions in skincancerRx power the FDA Approvals in Skin Cancer shiny app.

skincancerRx provides a set of verbs that wrangle, process and graph data related to FDA approvals in skin caner:

Verbs Function
fda_actions_per_disease_plot( ) generates a bar chart of the number of FDA approvals per type of skin cancer
fda_approval_timeliner_df( ) creates a data frame of FDA approval data that can then be used in the fda_approval_timeliner_plot() function
fda_approval_timeliner_plot( ) creates a data visualization of FDA approvals in skin cancer
fda_approval_timeseries_df( ) creates a data frame of FDA approval data that can then be used in the fda_approval_timeseries_plot() function
fda_approval_timeseries_plot( ) creates a data visualization of FDA approvals in skin cancer
response_rate_df( ) creates a data frame of FDA approval data that can then be used in the response_rate_plot() function
response_rate_plot( ) creates a data visualization of response rates of therapies approved via non-comparator trials
table_rx_skin_cancer( ) creates a table of FDA approvals in skin cancer

Software Dependencies

skincancerRx is written in R (version 4.0.0), organized using roxygen2, and utilizes the following packages dplyr, tidyr, readr, stringr, magrittr, plotly, splitstackshape.

Data Sources

To evaluate the evidence used to support labeled claims in skin cancer we reviewed FDA New Drug Application (NDA) or Biological License Application (BLA) reviews, and the US product labels, that are indexed on the FDA website (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm) . In addition to the product labels and NDA and BLA reviews, data were also obtained from OpenFDA (https://download.open.fda.gov/drug/drugsfda/drug-drugsfda-0001-of-0001.json.zip).

Installation

Development version

To get a bug fix or to use a feature from the development version, you can install the development version of skincancerRx from GitHub.

devtools::install_github("TheMillerLab/skincancerRx")

Usage

library(skincancerRx)

Examples

fda_actions_per_disease_plot( )

library(skincancerRx)

fda_actions_per_disease_plot(
  .xaxistextfont = 13,
  .xaxistitlefont = 16,
  .yaxistextfont = 14,
  .yaxistitlefont = 16,
  .plottitlefont = 18,
  .plotsubtitlefont = 16,
  .geomtextfont = 4)

fda_approval_timeliner_df()

library(kableExtra)
library(knitr)

fda_approval_timeliner_df() |> 
    kable() %>%
    kable_styling(bootstrap_options = c("striped","hover"),
                  fixed_thead = T) %>%
    scroll_box(height = "400px",
               width = "100%")
date name Dz Indication_brief Indication_short Mechanism Mechanism_long Mechanistic_Class y hover.a hover.b hover.c hover.d hover
1949-03-15 Mechlorethamine Hydrochloride CTCL Mycosis Fungoides Other Alkylating Agent Alkylating Agent Cytotoxic Agent 1 <b>Drug:</b> Mechlorethamine Hydrochloride <b>Date of Approval:</b> 1949-03-15 <b>Indication:</b> Mycosis Fungoides <b>Mechanism:</b> Alkylating Agent <b>Drug:</b> Mechlorethamine Hydrochloride<br><b>Date of Approval:</b> 1949-03-15<br><b>Indication:</b> Mycosis Fungoides<br><b>Mechanism:</b> Alkylating Agent
1950-06-13 Cortisone Acetate CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 2 <b>Drug:</b> Cortisone Acetate <b>Date of Approval:</b> 1950-06-13 <b>Indication:</b> Mycosis Fungoides <b>Mechanism:</b> Glucocorticoid <b>Drug:</b> Cortisone Acetate<br><b>Date of Approval:</b> 1950-06-13<br><b>Indication:</b> Mycosis Fungoides<br><b>Mechanism:</b> Glucocorticoid
1950-12-04 Cortisone Acetate CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 3 <b>Drug:</b> Cortisone Acetate <b>Date of Approval:</b> 1950-12-04 <b>Indication:</b> Mycosis Fungoides <b>Mechanism:</b> Glucocorticoid <b>Drug:</b> Cortisone Acetate<br><b>Date of Approval:</b> 1950-12-04<br><b>Indication:</b> Mycosis Fungoides<br><b>Mechanism:</b> Glucocorticoid
1952-12-15 Hydrocortisone CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 4 <b>Drug:</b> Hydrocortisone <b>Date of Approval:</b> 1952-12-15 <b>Indication:</b> Mycosis Fungoides <b>Mechanism:</b> Glucocorticoid <b>Drug:</b> Hydrocortisone<br><b>Date of Approval:</b> 1952-12-15<br><b>Indication:</b> Mycosis Fungoides<br><b>Mechanism:</b> Glucocorticoid
1953-12-07 Methotrexate Sodium CTCL Mycosis Fungoides Other Antimetabolite Antimetabolite Cytotoxic Agent 5 <b>Drug:</b> Methotrexate Sodium <b>Date of Approval:</b> 1953-12-07 <b>Indication:</b> Mycosis Fungoides <b>Mechanism:</b> Antimetabolite <b>Drug:</b> Methotrexate Sodium<br><b>Date of Approval:</b> 1953-12-07<br><b>Indication:</b> Mycosis Fungoides<br><b>Mechanism:</b> Antimetabolite
1955-02-21 Prednisone CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 6 <b>Drug:</b> Prednisone <b>Date of Approval:</b> 1955-02-21 <b>Indication:</b> Mycosis Fungoides <b>Mechanism:</b> Glucocorticoid <b>Drug:</b> Prednisone<br><b>Date of Approval:</b> 1955-02-21<br><b>Indication:</b> Mycosis Fungoides<br><b>Mechanism:</b> Glucocorticoid
1955-04-27 Hydrocortisone Sodium Succinate CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 7 <b>Drug:</b> Hydrocortisone Sodium Succinate <b>Date of Approval:</b> 1955-04-27 <b>Indication:</b> Mycosis Fungoides <b>Mechanism:</b> Glucocorticoid <b>Drug:</b> Hydrocortisone Sodium Succinate<br><b>Date of Approval:</b> 1955-04-27<br><b>Indication:</b> Mycosis Fungoides<br><b>Mechanism:</b> Glucocorticoid
1955-06-21 Prednisolone CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 8 <b>Drug:</b> Prednisolone <b>Date of Approval:</b> 1955-06-21 <b>Indication:</b> Mycosis Fungoides <b>Mechanism:</b> Glucocorticoid <b>Drug:</b> Prednisolone<br><b>Date of Approval:</b> 1955-06-21<br><b>Indication:</b> Mycosis Fungoides<br><b>Mechanism:</b> Glucocorticoid
1957-10-24 Methylprednisolone CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 9 <b>Drug:</b> Methylprednisolone <b>Date of Approval:</b> 1957-10-24 <b>Indication:</b> Mycosis Fungoides <b>Mechanism:</b> Glucocorticoid <b>Drug:</b> Methylprednisolone<br><b>Date of Approval:</b> 1957-10-24<br><b>Indication:</b> Mycosis Fungoides<br><b>Mechanism:</b> Glucocorticoid
1957-12-03 Triamcinolone CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 10 <b>Drug:</b> Triamcinolone <b>Date of Approval:</b> 1957-12-03 <b>Indication:</b> Mycosis Fungoides <b>Mechanism:</b> Glucocorticoid <b>Drug:</b> Triamcinolone<br><b>Date of Approval:</b> 1957-12-03<br><b>Indication:</b> Mycosis Fungoides<br><b>Mechanism:</b> Glucocorticoid
1958-10-30 Dexamethasone CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 11 <b>Drug:</b> Dexamethasone <b>Date of Approval:</b> 1958-10-30 <b>Indication:</b> Mycosis Fungoides <b>Mechanism:</b> Glucocorticoid <b>Drug:</b> Dexamethasone<br><b>Date of Approval:</b> 1958-10-30<br><b>Indication:</b> Mycosis Fungoides<br><b>Mechanism:</b> Glucocorticoid
1959-03-12 Triamcinolone Diacetate CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 12 <b>Drug:</b> Triamcinolone Diacetate <b>Date of Approval:</b> 1959-03-12 <b>Indication:</b> Mycosis Fungoides <b>Mechanism:</b> Glucocorticoid <b>Drug:</b> Triamcinolone Diacetate<br><b>Date of Approval:</b> 1959-03-12<br><b>Indication:</b> Mycosis Fungoides<br><b>Mechanism:</b> Glucocorticoid
1959-05-18 Methylprednisolone Sodium Succinate CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 13 <b>Drug:</b> Methylprednisolone Sodium Succinate <b>Date of Approval:</b> 1959-05-18 <b>Indication:</b> Mycosis Fungoides <b>Mechanism:</b> Glucocorticoid <b>Drug:</b> Methylprednisolone Sodium Succinate<br><b>Date of Approval:</b> 1959-05-18<br><b>Indication:</b> Mycosis Fungoides<br><b>Mechanism:</b> Glucocorticoid
1959-05-27 Methylprednisolone Acetate CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 14 <b>Drug:</b> Methylprednisolone Acetate <b>Date of Approval:</b> 1959-05-27 <b>Indication:</b> Mycosis Fungoides <b>Mechanism:</b> Glucocorticoid <b>Drug:</b> Methylprednisolone Acetate<br><b>Date of Approval:</b> 1959-05-27<br><b>Indication:</b> Mycosis Fungoides<br><b>Mechanism:</b> Glucocorticoid
1959-08-10 Methotrexate Sodium CTCL Mycosis Fungoides Other Antimetabolite Antimetabolite Cytotoxic Agent 15 <b>Drug:</b> Methotrexate Sodium <b>Date of Approval:</b> 1959-08-10 <b>Indication:</b> Mycosis Fungoides <b>Mechanism:</b> Antimetabolite <b>Drug:</b> Methotrexate Sodium<br><b>Date of Approval:</b> 1959-08-10<br><b>Indication:</b> Mycosis Fungoides<br><b>Mechanism:</b> Antimetabolite
1959-10-06 Dexamethasone Sodium Phosphate CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 16 <b>Drug:</b> Dexamethasone Sodium Phosphate <b>Date of Approval:</b> 1959-10-06 <b>Indication:</b> Mycosis Fungoides <b>Mechanism:</b> Glucocorticoid <b>Drug:</b> Dexamethasone Sodium Phosphate<br><b>Date of Approval:</b> 1959-10-06<br><b>Indication:</b> Mycosis Fungoides<br><b>Mechanism:</b> Glucocorticoid
1959-11-16 Cyclophosphamide CTCL Mycosis Fungoides Other Alkylating Agent Alkylating Agent Cytotoxic Agent 17 <b>Drug:</b> Cyclophosphamide <b>Date of Approval:</b> 1959-11-16 <b>Indication:</b> Mycosis Fungoides <b>Mechanism:</b> Alkylating Agent <b>Drug:</b> Cyclophosphamide<br><b>Date of Approval:</b> 1959-11-16<br><b>Indication:</b> Mycosis Fungoides<br><b>Mechanism:</b> Alkylating Agent
1959-11-16 Cyclophosphamide CTCL Mycosis Fungoides Other Alkylating Agent Alkylating Agent Cytotoxic Agent 18 <b>Drug:</b> Cyclophosphamide <b>Date of Approval:</b> 1959-11-16 <b>Indication:</b> Mycosis Fungoides <b>Mechanism:</b> Alkylating Agent <b>Drug:</b> Cyclophosphamide<br><b>Date of Approval:</b> 1959-11-16<br><b>Indication:</b> Mycosis Fungoides<br><b>Mechanism:</b> Alkylating Agent
1960-06-21 Methylprednisolone Acetate CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 19 <b>Drug:</b> Methylprednisolone Acetate <b>Date of Approval:</b> 1960-06-21 <b>Indication:</b> Mycosis Fungoides <b>Mechanism:</b> Glucocorticoid <b>Drug:</b> Methylprednisolone Acetate<br><b>Date of Approval:</b> 1960-06-21<br><b>Indication:</b> Mycosis Fungoides<br><b>Mechanism:</b> Glucocorticoid
1960-07-07 Dexamethasone CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 20 <b>Drug:</b> Dexamethasone <b>Date of Approval:</b> 1960-07-07 <b>Indication:</b> Mycosis Fungoides <b>Mechanism:</b> Glucocorticoid <b>Drug:</b> Dexamethasone<br><b>Date of Approval:</b> 1960-07-07<br><b>Indication:</b> Mycosis Fungoides<br><b>Mechanism:</b> Glucocorticoid
1961-04-17 Betamethasone CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 21 <b>Drug:</b> Betamethasone <b>Date of Approval:</b> 1961-04-17 <b>Indication:</b> Mycosis Fungoides <b>Mechanism:</b> Glucocorticoid <b>Drug:</b> Betamethasone<br><b>Date of Approval:</b> 1961-04-17<br><b>Indication:</b> Mycosis Fungoides<br><b>Mechanism:</b> Glucocorticoid
1961-09-05 Triamcinolone Diacetate CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 22 <b>Drug:</b> Triamcinolone Diacetate <b>Date of Approval:</b> 1961-09-05 <b>Indication:</b> Mycosis Fungoides <b>Mechanism:</b> Glucocorticoid <b>Drug:</b> Triamcinolone Diacetate<br><b>Date of Approval:</b> 1961-09-05<br><b>Indication:</b> Mycosis Fungoides<br><b>Mechanism:</b> Glucocorticoid
1965-02-01 Triamcinolone Acetonide CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 23 <b>Drug:</b> Triamcinolone Acetonide <b>Date of Approval:</b> 1965-02-01 <b>Indication:</b> Mycosis Fungoides <b>Mechanism:</b> Glucocorticoid <b>Drug:</b> Triamcinolone Acetonide<br><b>Date of Approval:</b> 1965-02-01<br><b>Indication:</b> Mycosis Fungoides<br><b>Mechanism:</b> Glucocorticoid
1965-03-03 Betamethasone Acetate CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 24 <b>Drug:</b> Betamethasone Acetate <b>Date of Approval:</b> 1965-03-03 <b>Indication:</b> Mycosis Fungoides <b>Mechanism:</b> Glucocorticoid <b>Drug:</b> Betamethasone Acetate<br><b>Date of Approval:</b> 1965-03-03<br><b>Indication:</b> Mycosis Fungoides<br><b>Mechanism:</b> Glucocorticoid
1965-11-25 Vinblastine Sulfate CTCL Mycosis Fungoides Other Microtubule Inhibitor Microtubule Inhibitor Cytotoxic Agent 25 <b>Drug:</b> Vinblastine Sulfate <b>Date of Approval:</b> 1965-11-25 <b>Indication:</b> Mycosis Fungoides <b>Mechanism:</b> Microtubule Inhibitor <b>Drug:</b> Vinblastine Sulfate<br><b>Date of Approval:</b> 1965-11-25<br><b>Indication:</b> Mycosis Fungoides<br><b>Mechanism:</b> Microtubule Inhibitor
1965-11-25 Vinblastine Sulfate KS Kaposi's Sarcoma Other Microtubule Inhibitor Microtubule Inhibitor Cytotoxic Agent 26 <b>Drug:</b> Vinblastine Sulfate <b>Date of Approval:</b> 1965-11-25 <b>Indication:</b> Kaposi's Sarcoma <b>Mechanism:</b> Microtubule Inhibitor <b>Drug:</b> Vinblastine Sulfate<br><b>Date of Approval:</b> 1965-11-25<br><b>Indication:</b> Kaposi's Sarcoma<br><b>Mechanism:</b> Microtubule Inhibitor
1967-12-07 Hydroxyurea Melanoma Melanoma Other Antimetabolite Antimetabolite Cytotoxic Agent 27 <b>Drug:</b> Hydroxyurea <b>Date of Approval:</b> 1967-12-07 <b>Indication:</b> Melanoma <b>Mechanism:</b> Antimetabolite <b>Drug:</b> Hydroxyurea<br><b>Date of Approval:</b> 1967-12-07<br><b>Indication:</b> Melanoma<br><b>Mechanism:</b> Antimetabolite
1970-07-29 Fluorouracil AK Multiple Actinic Keratoses Other Antimetabolite Antimetabolite Cytotoxic Agent 28 <b>Drug:</b> Fluorouracil <b>Date of Approval:</b> 1970-07-29 <b>Indication:</b> Multiple Actinic Keratoses <b>Mechanism:</b> Antimetabolite <b>Drug:</b> Fluorouracil<br><b>Date of Approval:</b> 1970-07-29<br><b>Indication:</b> Multiple Actinic Keratoses<br><b>Mechanism:</b> Antimetabolite
1971-08-06 Fluorouracil AK Actinic Keratoses Other Antimetabolite Antimetabolite Cytotoxic Agent 29 <b>Drug:</b> Fluorouracil <b>Date of Approval:</b> 1971-08-06 <b>Indication:</b> Actinic Keratoses <b>Mechanism:</b> Antimetabolite <b>Drug:</b> Fluorouracil<br><b>Date of Approval:</b> 1971-08-06<br><b>Indication:</b> Actinic Keratoses<br><b>Mechanism:</b> Antimetabolite
1975-05-27 Dacarbazine Melanoma Metastatic Malignant Melanoma Metastatic Alkylating Agent Alkylating Agent Cytotoxic Agent 30 <b>Drug:</b> Dacarbazine <b>Date of Approval:</b> 1975-05-27 <b>Indication:</b> Metastatic Malignant Melanoma <b>Mechanism:</b> Alkylating Agent <b>Drug:</b> Dacarbazine<br><b>Date of Approval:</b> 1975-05-27<br><b>Indication:</b> Metastatic Malignant Melanoma<br><b>Mechanism:</b> Alkylating Agent
1975-06-30 Fluorouracil BCC Superficial Basal Cell Carcinoma Other Antimetabolite Antimetabolite Cytotoxic Agent 31 <b>Drug:</b> Fluorouracil <b>Date of Approval:</b> 1975-06-30 <b>Indication:</b> Superficial Basal Cell Carcinoma <b>Mechanism:</b> Antimetabolite <b>Drug:</b> Fluorouracil<br><b>Date of Approval:</b> 1975-06-30<br><b>Indication:</b> Superficial Basal Cell Carcinoma<br><b>Mechanism:</b> Antimetabolite
1986-05-28 Prednisolone Sodium Phosphate CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 32 <b>Drug:</b> Prednisolone Sodium Phosphate <b>Date of Approval:</b> 1986-05-28 <b>Indication:</b> Mycosis Fungoides <b>Mechanism:</b> Glucocorticoid <b>Drug:</b> Prednisolone Sodium Phosphate<br><b>Date of Approval:</b> 1986-05-28<br><b>Indication:</b> Mycosis Fungoides<br><b>Mechanism:</b> Glucocorticoid
1988-03-23 Methoxsalen CTCL Refractory Cutaneous T-Cell Lymphoma Refractory Phototoxic Phototoxic Agent Cytotoxic Agent 33 <b>Drug:</b> Methoxsalen <b>Date of Approval:</b> 1988-03-23 <b>Indication:</b> Refractory Cutaneous T-Cell Lymphoma <b>Mechanism:</b> Phototoxic <b>Drug:</b> Methoxsalen<br><b>Date of Approval:</b> 1988-03-23<br><b>Indication:</b> Refractory Cutaneous T-Cell Lymphoma<br><b>Mechanism:</b> Phototoxic
1988-11-21 Interferon Alfa-2b KS AIDS-Related Kaposi's Sarcoma Other Cytokine Cytokine Immunotherapy 34 <b>Drug:</b> Interferon Alfa-2b <b>Date of Approval:</b> 1988-11-21 <b>Indication:</b> AIDS-Related Kaposi's Sarcoma <b>Mechanism:</b> Cytokine <b>Drug:</b> Interferon Alfa-2b<br><b>Date of Approval:</b> 1988-11-21<br><b>Indication:</b> AIDS-Related Kaposi's Sarcoma<br><b>Mechanism:</b> Cytokine
1988-11-21 Interferon Alfa-2a KS AIDS-Related Kaposi's Sarcoma Other Cytokine Cytokine Immunotherapy 35 <b>Drug:</b> Interferon Alfa-2a <b>Date of Approval:</b> 1988-11-21 <b>Indication:</b> AIDS-Related Kaposi's Sarcoma <b>Mechanism:</b> Cytokine <b>Drug:</b> Interferon Alfa-2a<br><b>Date of Approval:</b> 1988-11-21<br><b>Indication:</b> AIDS-Related Kaposi's Sarcoma<br><b>Mechanism:</b> Cytokine
1995-11-17 Doxorubicin Hydrochloride KS Accelerated Approval for Refractory AIDS-Related Kaposi's Sarcoma Refractory Topoisomerase Inhibitor Topoisomerase Inhibitor Cytotoxic Agent 36 <b>Drug:</b> Doxorubicin Hydrochloride <b>Date of Approval:</b> 1995-11-17 <b>Indication:</b> Accelerated Approval for Refractory AIDS-Related Kaposi's Sarcoma <b>Mechanism:</b> Topoisomerase Inhibitor <b>Drug:</b> Doxorubicin Hydrochloride<br><b>Date of Approval:</b> 1995-11-17<br><b>Indication:</b> Accelerated Approval for Refractory AIDS-Related Kaposi's Sarcoma<br><b>Mechanism:</b> Topoisomerase Inhibitor
1995-12-05 Interferon Alfa-2b Melanoma Adjuvant Melanoma Adjuvant Cytokine Cytokine Immunotherapy 37 <b>Drug:</b> Interferon Alfa-2b <b>Date of Approval:</b> 1995-12-05 <b>Indication:</b> Adjuvant Melanoma <b>Mechanism:</b> Cytokine <b>Drug:</b> Interferon Alfa-2b<br><b>Date of Approval:</b> 1995-12-05<br><b>Indication:</b> Adjuvant Melanoma<br><b>Mechanism:</b> Cytokine
1996-04-08 Daunorubicin Citrate KS HIV-associated Kaposi's Sarcoma - First Line Other Topoisomerase Inhibitor Topoisomerase Inhibitor Cytotoxic Agent 38 <b>Drug:</b> Daunorubicin Citrate <b>Date of Approval:</b> 1996-04-08 <b>Indication:</b> HIV-associated Kaposi's Sarcoma - First Line <b>Mechanism:</b> Topoisomerase Inhibitor <b>Drug:</b> Daunorubicin Citrate<br><b>Date of Approval:</b> 1996-04-08<br><b>Indication:</b> HIV-associated Kaposi's Sarcoma - First Line<br><b>Mechanism:</b> Topoisomerase Inhibitor
1997-08-04 Paclitaxel KS AIDS-Related Kaposi's Sarcoma - Second Line Refractory Microtubule Stabilizer Microtubule Stabilizer Cytotoxic Agent 39 <b>Drug:</b> Paclitaxel <b>Date of Approval:</b> 1997-08-04 <b>Indication:</b> AIDS-Related Kaposi's Sarcoma - Second Line <b>Mechanism:</b> Microtubule Stabilizer <b>Drug:</b> Paclitaxel<br><b>Date of Approval:</b> 1997-08-04<br><b>Indication:</b> AIDS-Related Kaposi's Sarcoma - Second Line<br><b>Mechanism:</b> Microtubule Stabilizer
1998-01-09 Aldesleukin Melanoma Metastatic Melanoma Metastatic Cytokine Cytokine Immunotherapy 40 <b>Drug:</b> Aldesleukin <b>Date of Approval:</b> 1998-01-09 <b>Indication:</b> Metastatic Melanoma <b>Mechanism:</b> Cytokine <b>Drug:</b> Aldesleukin<br><b>Date of Approval:</b> 1998-01-09<br><b>Indication:</b> Metastatic Melanoma<br><b>Mechanism:</b> Cytokine
1998-12-17 Prednisolone Sodium Phosphate CTCL Expansion to include pediatric populations Other Glucocorticoid Glucocorticoid Glucocorticoid 41 <b>Drug:</b> Prednisolone Sodium Phosphate <b>Date of Approval:</b> 1998-12-17 <b>Indication:</b> Expansion to include pediatric populations <b>Mechanism:</b> Glucocorticoid <b>Drug:</b> Prednisolone Sodium Phosphate<br><b>Date of Approval:</b> 1998-12-17<br><b>Indication:</b> Expansion to include pediatric populations<br><b>Mechanism:</b> Glucocorticoid
1999-02-02 Alitretinoin KS AIDS-Related Kaposi's Sarcoma - Cutaneous Lesions Only Other Retinoid Retinoid Retinoid 42 <b>Drug:</b> Alitretinoin <b>Date of Approval:</b> 1999-02-02 <b>Indication:</b> AIDS-Related Kaposi's Sarcoma - Cutaneous Lesions Only <b>Mechanism:</b> Retinoid <b>Drug:</b> Alitretinoin<br><b>Date of Approval:</b> 1999-02-02<br><b>Indication:</b> AIDS-Related Kaposi's Sarcoma - Cutaneous Lesions Only<br><b>Mechanism:</b> Retinoid
1999-02-05 Denileukin Diftitox CTCL Accelerated Approval for Persistent or Recurrent CD25+ Cutaneous T-Cell Lymphoma Other Cytokine-Cytotoxin Cytokine-Cytotoxin Cytotoxic Agent 43 <b>Drug:</b> Denileukin Diftitox <b>Date of Approval:</b> 1999-02-05 <b>Indication:</b> Accelerated Approval for Persistent or Recurrent CD25+ Cutaneous T-Cell Lymphoma <b>Mechanism:</b> Cytokine-Cytotoxin <b>Drug:</b> Denileukin Diftitox<br><b>Date of Approval:</b> 1999-02-05<br><b>Indication:</b> Accelerated Approval for Persistent or Recurrent CD25+ Cutaneous T-Cell Lymphoma<br><b>Mechanism:</b> Cytokine-Cytotoxin
1999-02-25 Methoxsalen CTCL Refractory Cutaneous T-Cell Lymphoma Refractory Phototoxic Phototoxic Agent Cytotoxic Agent 44 <b>Drug:</b> Methoxsalen <b>Date of Approval:</b> 1999-02-25 <b>Indication:</b> Refractory Cutaneous T-Cell Lymphoma <b>Mechanism:</b> Phototoxic <b>Drug:</b> Methoxsalen<br><b>Date of Approval:</b> 1999-02-25<br><b>Indication:</b> Refractory Cutaneous T-Cell Lymphoma<br><b>Mechanism:</b> Phototoxic
1999-12-03 Aminolevulinic Acid Hydrochloride AK Non-Hyperkeratotic Actinic Keratoses of the Face or Scalp Other Phototoxic Phototoxic Agent Cytotoxic Agent 45 <b>Drug:</b> Aminolevulinic Acid Hydrochloride <b>Date of Approval:</b> 1999-12-03 <b>Indication:</b> Non-Hyperkeratotic Actinic Keratoses of the Face or Scalp <b>Mechanism:</b> Phototoxic <b>Drug:</b> Aminolevulinic Acid Hydrochloride<br><b>Date of Approval:</b> 1999-12-03<br><b>Indication:</b> Non-Hyperkeratotic Actinic Keratoses of the Face or Scalp<br><b>Mechanism:</b> Phototoxic
1999-12-29 Bexarotene CTCL Refractory Cutaneous T-Cell Lymphoma Refractory Retinoid Retinoid Retinoid 46 <b>Drug:</b> Bexarotene <b>Date of Approval:</b> 1999-12-29 <b>Indication:</b> Refractory Cutaneous T-Cell Lymphoma <b>Mechanism:</b> Retinoid <b>Drug:</b> Bexarotene<br><b>Date of Approval:</b> 1999-12-29<br><b>Indication:</b> Refractory Cutaneous T-Cell Lymphoma<br><b>Mechanism:</b> Retinoid
2000-06-28 Bexarotene CTCL Refractory Stage IA and IB Cutaneous T-Cell Lymphoma Refractory Retinoid Retinoid Retinoid 47 <b>Drug:</b> Bexarotene <b>Date of Approval:</b> 2000-06-28 <b>Indication:</b> Refractory Stage IA and IB Cutaneous T-Cell Lymphoma <b>Mechanism:</b> Retinoid <b>Drug:</b> Bexarotene<br><b>Date of Approval:</b> 2000-06-28<br><b>Indication:</b> Refractory Stage IA and IB Cutaneous T-Cell Lymphoma<br><b>Mechanism:</b> Retinoid
2000-10-16 Diclofenac Sodium AK Actinic Keratoses Other NSAID NSAID NSAID 48 <b>Drug:</b> Diclofenac Sodium <b>Date of Approval:</b> 2000-10-16 <b>Indication:</b> Actinic Keratoses <b>Mechanism:</b> NSAID <b>Drug:</b> Diclofenac Sodium<br><b>Date of Approval:</b> 2000-10-16<br><b>Indication:</b> Actinic Keratoses<br><b>Mechanism:</b> NSAID
2000-10-27 Fluorouracil AK Multiple Actinic Keratoses of the Face and Anterior Scalp Other Antimetabolite Antimetabolite Cytotoxic Agent 49 <b>Drug:</b> Fluorouracil <b>Date of Approval:</b> 2000-10-27 <b>Indication:</b> Multiple Actinic Keratoses of the Face and Anterior Scalp <b>Mechanism:</b> Antimetabolite <b>Drug:</b> Fluorouracil<br><b>Date of Approval:</b> 2000-10-27<br><b>Indication:</b> Multiple Actinic Keratoses of the Face and Anterior Scalp<br><b>Mechanism:</b> Antimetabolite
2004-03-02 Imiquimod AK Nonhypertrophic Actinic Keratoses on the Face or Scalp Other TLR Agonist TLR Agonist Immunotherapy 50 <b>Drug:</b> Imiquimod <b>Date of Approval:</b> 2004-03-02 <b>Indication:</b> Nonhypertrophic Actinic Keratoses on the Face or Scalp <b>Mechanism:</b> TLR Agonist <b>Drug:</b> Imiquimod<br><b>Date of Approval:</b> 2004-03-02<br><b>Indication:</b> Nonhypertrophic Actinic Keratoses on the Face or Scalp<br><b>Mechanism:</b> TLR Agonist
2004-07-14 Imiquimod BCC Superficial Basal Cell Carcinoma Other TLR Agonist TLR Agonist Immunotherapy 51 <b>Drug:</b> Imiquimod <b>Date of Approval:</b> 2004-07-14 <b>Indication:</b> Superficial Basal Cell Carcinoma <b>Mechanism:</b> TLR Agonist <b>Drug:</b> Imiquimod<br><b>Date of Approval:</b> 2004-07-14<br><b>Indication:</b> Superficial Basal Cell Carcinoma<br><b>Mechanism:</b> TLR Agonist
2004-07-27 Methyl Aminolevulinate Hydrochloride AK Non-Keratotic Actinic Keratoses of the Face and Scalp Other Phototoxic Phototoxic Agent Cytotoxic Agent 52 <b>Drug:</b> Methyl Aminolevulinate Hydrochloride <b>Date of Approval:</b> 2004-07-27 <b>Indication:</b> Non-Keratotic Actinic Keratoses of the Face and Scalp <b>Mechanism:</b> Phototoxic <b>Drug:</b> Methyl Aminolevulinate Hydrochloride<br><b>Date of Approval:</b> 2004-07-27<br><b>Indication:</b> Non-Keratotic Actinic Keratoses of the Face and Scalp<br><b>Mechanism:</b> Phototoxic
2006-06-01 Prednisolone Sodium Phosphate CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 53 <b>Drug:</b> Prednisolone Sodium Phosphate <b>Date of Approval:</b> 2006-06-01 <b>Indication:</b> Mycosis Fungoides <b>Mechanism:</b> Glucocorticoid <b>Drug:</b> Prednisolone Sodium Phosphate<br><b>Date of Approval:</b> 2006-06-01<br><b>Indication:</b> Mycosis Fungoides<br><b>Mechanism:</b> Glucocorticoid
2006-10-06 Vorinostat CTCL Refractory Cutaneous T-Cell Lymphoma Refractory HDAC Inhibitor HDAC Inhibitor Targeted Therapy 54 <b>Drug:</b> Vorinostat <b>Date of Approval:</b> 2006-10-06 <b>Indication:</b> Refractory Cutaneous T-Cell Lymphoma <b>Mechanism:</b> HDAC Inhibitor <b>Drug:</b> Vorinostat<br><b>Date of Approval:</b> 2006-10-06<br><b>Indication:</b> Refractory Cutaneous T-Cell Lymphoma<br><b>Mechanism:</b> HDAC Inhibitor
2006-10-19 Imatinib Mesylate DFSP Unresectable, Recurrent and/or Metastatic Dermatofibrosarcoma Protuberans Locally Advanced or Metastatic Kinase Inhibitor Kinase Inhibitor Targeted Therapy 55 <b>Drug:</b> Imatinib Mesylate <b>Date of Approval:</b> 2006-10-19 <b>Indication:</b> Unresectable, Recurrent and/or Metastatic Dermatofibrosarcoma Protuberans <b>Mechanism:</b> Kinase Inhibitor <b>Drug:</b> Imatinib Mesylate<br><b>Date of Approval:</b> 2006-10-19<br><b>Indication:</b> Unresectable, Recurrent and/or Metastatic Dermatofibrosarcoma Protuberans<br><b>Mechanism:</b> Kinase Inhibitor
2008-01-17 Prednisolone Acetate CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 56 <b>Drug:</b> Prednisolone Acetate <b>Date of Approval:</b> 2008-01-17 <b>Indication:</b> Mycosis Fungoides <b>Mechanism:</b> Glucocorticoid <b>Drug:</b> Prednisolone Acetate<br><b>Date of Approval:</b> 2008-01-17<br><b>Indication:</b> Mycosis Fungoides<br><b>Mechanism:</b> Glucocorticoid
2008-06-10 Doxorubicin Hydrochloride KS Regular Aprroval for Refractory AIDS-Related Kaposi's Sarcoma Refractory Topoisomerase Inhibitor Topoisomerase Inhibitor Cytotoxic Agent 57 <b>Drug:</b> Doxorubicin Hydrochloride <b>Date of Approval:</b> 2008-06-10 <b>Indication:</b> Regular Aprroval for Refractory AIDS-Related Kaposi's Sarcoma <b>Mechanism:</b> Topoisomerase Inhibitor <b>Drug:</b> Doxorubicin Hydrochloride<br><b>Date of Approval:</b> 2008-06-10<br><b>Indication:</b> Regular Aprroval for Refractory AIDS-Related Kaposi's Sarcoma<br><b>Mechanism:</b> Topoisomerase Inhibitor
2008-06-16 Triamcinolone Acetonide CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 58 <b>Drug:</b> Triamcinolone Acetonide <b>Date of Approval:</b> 2008-06-16 <b>Indication:</b> Mycosis Fungoides <b>Mechanism:</b> Glucocorticoid <b>Drug:</b> Triamcinolone Acetonide<br><b>Date of Approval:</b> 2008-06-16<br><b>Indication:</b> Mycosis Fungoides<br><b>Mechanism:</b> Glucocorticoid
2008-06-26 Methyl Aminolevulinate Hydrochloride AK Use of Metvixia with a new Lamp (Aktilite) in AKs Other Phototoxic Phototoxic Agent Cytotoxic Agent 59 <b>Drug:</b> Methyl Aminolevulinate Hydrochloride <b>Date of Approval:</b> 2008-06-26 <b>Indication:</b> Use of Metvixia with a new Lamp (Aktilite) in AKs <b>Mechanism:</b> Phototoxic <b>Drug:</b> Methyl Aminolevulinate Hydrochloride<br><b>Date of Approval:</b> 2008-06-26<br><b>Indication:</b> Use of Metvixia with a new Lamp (Aktilite) in AKs<br><b>Mechanism:</b> Phototoxic
2008-10-15 Denileukin Diftitox CTCL Regular Approval for Persistent or Recurrent CD25+ Cutaneous T-Cell Lymphoma Other Cytokine-Cytotoxin Cytokine-Cytotoxin Cytotoxic Agent 60 <b>Drug:</b> Denileukin Diftitox <b>Date of Approval:</b> 2008-10-15 <b>Indication:</b> Regular Approval for Persistent or Recurrent CD25+ Cutaneous T-Cell Lymphoma <b>Mechanism:</b> Cytokine-Cytotoxin <b>Drug:</b> Denileukin Diftitox<br><b>Date of Approval:</b> 2008-10-15<br><b>Indication:</b> Regular Approval for Persistent or Recurrent CD25+ Cutaneous T-Cell Lymphoma<br><b>Mechanism:</b> Cytokine-Cytotoxin
2009-11-05 Romidepsin CTCL Refractory Cutaneous T-Cell Lymphoma Refractory HDAC Inhibitor HDAC Inhibitor HDAC Inhibitor 61 <b>Drug:</b> Romidepsin <b>Date of Approval:</b> 2009-11-05 <b>Indication:</b> Refractory Cutaneous T-Cell Lymphoma <b>Mechanism:</b> HDAC Inhibitor <b>Drug:</b> Romidepsin<br><b>Date of Approval:</b> 2009-11-05<br><b>Indication:</b> Refractory Cutaneous T-Cell Lymphoma<br><b>Mechanism:</b> HDAC Inhibitor
2010-03-12 Aminolevulinic Acid Hydrochloride AK Allow user to mix contents for 30 seconds prior to use & to use 'Kerastick Krusher' Other Phototoxic Phototoxic Agent Cytotoxic Agent 62 <b>Drug:</b> Aminolevulinic Acid Hydrochloride <b>Date of Approval:</b> 2010-03-12 <b>Indication:</b> Allow user to mix contents for 30 seconds prior to use & to use 'Kerastick Krusher' <b>Mechanism:</b> Phototoxic <b>Drug:</b> Aminolevulinic Acid Hydrochloride<br><b>Date of Approval:</b> 2010-03-12<br><b>Indication:</b> Allow user to mix contents for 30 seconds prior to use & to use 'Kerastick Krusher'<br><b>Mechanism:</b> Phototoxic
2010-03-25 Imiquimod AK Use of 3.75% form for Actinic Keratoses of the Full Face or Balding Scalp Other TLR Agonist TLR Agonist Immunotherapy 63 <b>Drug:</b> Imiquimod <b>Date of Approval:</b> 2010-03-25 <b>Indication:</b> Use of 3.75% form for Actinic Keratoses of the Full Face or Balding Scalp <b>Mechanism:</b> TLR Agonist <b>Drug:</b> Imiquimod<br><b>Date of Approval:</b> 2010-03-25<br><b>Indication:</b> Use of 3.75% form for Actinic Keratoses of the Full Face or Balding Scalp<br><b>Mechanism:</b> TLR Agonist
2011-03-25 Ipilimumab Melanoma Unresectable or Metastatic Melanoma Locally Advanced or Metastatic CTLA-4 Ab CTLA-4 Targeted Antibody Immunotherapy 64 <b>Drug:</b> Ipilimumab <b>Date of Approval:</b> 2011-03-25 <b>Indication:</b> Unresectable or Metastatic Melanoma <b>Mechanism:</b> CTLA-4 Ab <b>Drug:</b> Ipilimumab<br><b>Date of Approval:</b> 2011-03-25<br><b>Indication:</b> Unresectable or Metastatic Melanoma<br><b>Mechanism:</b> CTLA-4 Ab
2011-03-29 Peginterferon Alfa-2b Melanoma Adjuvant Melanoma Adjuvant Cytokine Cytokine Immunotherapy 65 <b>Drug:</b> Peginterferon Alfa-2b <b>Date of Approval:</b> 2011-03-29 <b>Indication:</b> Adjuvant Melanoma <b>Mechanism:</b> Cytokine <b>Drug:</b> Peginterferon Alfa-2b<br><b>Date of Approval:</b> 2011-03-29<br><b>Indication:</b> Adjuvant Melanoma<br><b>Mechanism:</b> Cytokine
2011-07-15 Imiquimod AK Use of 2.5% cream for AKs on face and scalp Other TLR Agonist TLR Agonist Immunotherapy 66 <b>Drug:</b> Imiquimod <b>Date of Approval:</b> 2011-07-15 <b>Indication:</b> Use of 2.5% cream for AKs on face and scalp <b>Mechanism:</b> TLR Agonist <b>Drug:</b> Imiquimod<br><b>Date of Approval:</b> 2011-07-15<br><b>Indication:</b> Use of 2.5% cream for AKs on face and scalp<br><b>Mechanism:</b> TLR Agonist
2011-08-17 Vemurafenib Melanoma Unresectable or Metastatic Melanoma Locally Advanced or Metastatic Kinase Inhibitor Kinase Inhibitor Targeted Therapy 67 <b>Drug:</b> Vemurafenib <b>Date of Approval:</b> 2011-08-17 <b>Indication:</b> Unresectable or Metastatic Melanoma <b>Mechanism:</b> Kinase Inhibitor <b>Drug:</b> Vemurafenib<br><b>Date of Approval:</b> 2011-08-17<br><b>Indication:</b> Unresectable or Metastatic Melanoma<br><b>Mechanism:</b> Kinase Inhibitor
2012-01-23 Ingenol Mebutate AK Actinic Keratoses Other Cytotoxic Agent Cytotoxic Agent Cytotoxic Agent 68 <b>Drug:</b> Ingenol Mebutate <b>Date of Approval:</b> 2012-01-23 <b>Indication:</b> Actinic Keratoses <b>Mechanism:</b> Cytotoxic Agent <b>Drug:</b> Ingenol Mebutate<br><b>Date of Approval:</b> 2012-01-23<br><b>Indication:</b> Actinic Keratoses<br><b>Mechanism:</b> Cytotoxic Agent
2012-01-30 Vismodegib BCC Locally Advanced or Metastatic Basal Cell Carcinoma Locally Advanced or Metastatic Smoothened Inhibitor Smoothened Inhibitor Targeted Therapy 69 <b>Drug:</b> Vismodegib <b>Date of Approval:</b> 2012-01-30 <b>Indication:</b> Locally Advanced or Metastatic Basal Cell Carcinoma <b>Mechanism:</b> Smoothened Inhibitor <b>Drug:</b> Vismodegib<br><b>Date of Approval:</b> 2012-01-30<br><b>Indication:</b> Locally Advanced or Metastatic Basal Cell Carcinoma<br><b>Mechanism:</b> Smoothened Inhibitor
2013-05-29 Trametinib Dimethyl Sulfoxide Melanoma Unresectable or Metastatic BRAF-Mutated Melanoma Locally Advanced or Metastatic Kinase Inhibitor Kinase Inhibitor Targeted Therapy 70 <b>Drug:</b> Trametinib Dimethyl Sulfoxide <b>Date of Approval:</b> 2013-05-29 <b>Indication:</b> Unresectable or Metastatic BRAF-Mutated Melanoma <b>Mechanism:</b> Kinase Inhibitor <b>Drug:</b> Trametinib Dimethyl Sulfoxide<br><b>Date of Approval:</b> 2013-05-29<br><b>Indication:</b> Unresectable or Metastatic BRAF-Mutated Melanoma<br><b>Mechanism:</b> Kinase Inhibitor
2013-05-29 Dabrafenib Mesylate Melanoma Single agent, first-line in advanced BRAF-mutated melanoma Locally Advanced or Metastatic Kinase Inhibitor Kinase Inhibitor Targeted Therapy 71 <b>Drug:</b> Dabrafenib Mesylate <b>Date of Approval:</b> 2013-05-29 <b>Indication:</b> Single agent, first-line in advanced BRAF-mutated melanoma <b>Mechanism:</b> Kinase Inhibitor <b>Drug:</b> Dabrafenib Mesylate<br><b>Date of Approval:</b> 2013-05-29<br><b>Indication:</b> Single agent, first-line in advanced BRAF-mutated melanoma<br><b>Mechanism:</b> Kinase Inhibitor
2013-08-23 Mechlorethamine Hydrochloride CTCL Refractory Stage IA and IB Cutaneous T-Cell Lymphoma Refractory Alkylating Agent Alkylating Agent Cytotoxic Agent 72 <b>Drug:</b> Mechlorethamine Hydrochloride <b>Date of Approval:</b> 2013-08-23 <b>Indication:</b> Refractory Stage IA and IB Cutaneous T-Cell Lymphoma <b>Mechanism:</b> Alkylating Agent <b>Drug:</b> Mechlorethamine Hydrochloride<br><b>Date of Approval:</b> 2013-08-23<br><b>Indication:</b> Refractory Stage IA and IB Cutaneous T-Cell Lymphoma<br><b>Mechanism:</b> Alkylating Agent
2014-01-08 Trametinib Dimethyl Sulfoxide Melanoma Unresectable or Metastatic BRAF-Mutated Melanoma Locally Advanced or Metastatic Kinase Inhibitor Kinase Inhibitor Targeted Therapy 73 <b>Drug:</b> Trametinib Dimethyl Sulfoxide <b>Date of Approval:</b> 2014-01-08 <b>Indication:</b> Unresectable or Metastatic BRAF-Mutated Melanoma <b>Mechanism:</b> Kinase Inhibitor <b>Drug:</b> Trametinib Dimethyl Sulfoxide<br><b>Date of Approval:</b> 2014-01-08<br><b>Indication:</b> Unresectable or Metastatic BRAF-Mutated Melanoma<br><b>Mechanism:</b> Kinase Inhibitor
2014-01-09 Dabrafenib Mesylate Melanoma Accelerated approval for Dab/Tram in advanced BRAF mutant melanoma Locally Advanced or Metastatic Kinase Inhibitor Kinase Inhibitor Targeted Therapy 74 <b>Drug:</b> Dabrafenib Mesylate <b>Date of Approval:</b> 2014-01-09 <b>Indication:</b> Accelerated approval for Dab/Tram in advanced BRAF mutant melanoma <b>Mechanism:</b> Kinase Inhibitor <b>Drug:</b> Dabrafenib Mesylate<br><b>Date of Approval:</b> 2014-01-09<br><b>Indication:</b> Accelerated approval for Dab/Tram in advanced BRAF mutant melanoma<br><b>Mechanism:</b> Kinase Inhibitor
2014-09-04 Pembrolizumab Melanoma Unresectable or Metastatic Melanoma - Second Line Refractory PD-1 Ab PD-1 Targeted Antibody Immunotherapy 75 <b>Drug:</b> Pembrolizumab <b>Date of Approval:</b> 2014-09-04 <b>Indication:</b> Unresectable or Metastatic Melanoma - Second Line <b>Mechanism:</b> PD-1 Ab <b>Drug:</b> Pembrolizumab<br><b>Date of Approval:</b> 2014-09-04<br><b>Indication:</b> Unresectable or Metastatic Melanoma - Second Line<br><b>Mechanism:</b> PD-1 Ab
2014-12-22 Nivolumab Melanoma Accelerated Approval for Unresectable or Metastatic Melanoma in the Second-Line Setting Locally Advanced or Metastatic PD-1 Ab PD-1 Targeted Antibody Immunotherapy 76 <b>Drug:</b> Nivolumab <b>Date of Approval:</b> 2014-12-22 <b>Indication:</b> Accelerated Approval for Unresectable or Metastatic Melanoma in the Second-Line Setting <b>Mechanism:</b> PD-1 Ab <b>Drug:</b> Nivolumab<br><b>Date of Approval:</b> 2014-12-22<br><b>Indication:</b> Accelerated Approval for Unresectable or Metastatic Melanoma in the Second-Line Setting<br><b>Mechanism:</b> PD-1 Ab
2015-07-24 Sonidegib Phosphate BCC Locally Advanced Basal Cell Carcinoma Locally Advanced Smoothened Inhibitor Smoothened Inhibitor Targeted Therapy 77 <b>Drug:</b> Sonidegib Phosphate <b>Date of Approval:</b> 2015-07-24 <b>Indication:</b> Locally Advanced Basal Cell Carcinoma <b>Mechanism:</b> Smoothened Inhibitor <b>Drug:</b> Sonidegib Phosphate<br><b>Date of Approval:</b> 2015-07-24<br><b>Indication:</b> Locally Advanced Basal Cell Carcinoma<br><b>Mechanism:</b> Smoothened Inhibitor
2015-09-30 Nivolumab Melanoma Accelerated Approval of OPDIVO with YERVOY in BRAF Wild Type Unresectable or Metastatic Melanoma Locally Advanced or Metastatic PD-1 Ab PD-1 Targeted Antibody Immunotherapy 78 <b>Drug:</b> Nivolumab <b>Date of Approval:</b> 2015-09-30 <b>Indication:</b> Accelerated Approval of OPDIVO with YERVOY in BRAF Wild Type Unresectable or Metastatic Melanoma <b>Mechanism:</b> PD-1 Ab <b>Drug:</b> Nivolumab<br><b>Date of Approval:</b> 2015-09-30<br><b>Indication:</b> Accelerated Approval of OPDIVO with YERVOY in BRAF Wild Type Unresectable or Metastatic Melanoma<br><b>Mechanism:</b> PD-1 Ab
2015-10-27 Talimogene Laherparepvec Melanoma Unresectable Cutaneous, Subcutaneous, and Nodal Recurrent Melanoma Locally Advanced Oncolytic Virus Oncolytic Virus Immunotherapy 79 <b>Drug:</b> Talimogene Laherparepvec <b>Date of Approval:</b> 2015-10-27 <b>Indication:</b> Unresectable Cutaneous, Subcutaneous, and Nodal Recurrent Melanoma <b>Mechanism:</b> Oncolytic Virus <b>Drug:</b> Talimogene Laherparepvec<br><b>Date of Approval:</b> 2015-10-27<br><b>Indication:</b> Unresectable Cutaneous, Subcutaneous, and Nodal Recurrent Melanoma<br><b>Mechanism:</b> Oncolytic Virus
2015-10-28 Ipilimumab Melanoma Adjuvant Melanoma Adjuvant CTLA-4 Ab CTLA-4 Targeted Antibody Immunotherapy 80 <b>Drug:</b> Ipilimumab <b>Date of Approval:</b> 2015-10-28 <b>Indication:</b> Adjuvant Melanoma <b>Mechanism:</b> CTLA-4 Ab <b>Drug:</b> Ipilimumab<br><b>Date of Approval:</b> 2015-10-28<br><b>Indication:</b> Adjuvant Melanoma<br><b>Mechanism:</b> CTLA-4 Ab
2015-11-10 Cobimetinib Fumarate Melanoma Unresectable or Metastatic Melanoma with a BRAF-Mutated Melanoma In Combination with Vemurafenib Locally Advanced or Metastatic Kinase Inhibitor Kinase Inhibitor Targeted Therapy 81 <b>Drug:</b> Cobimetinib Fumarate <b>Date of Approval:</b> 2015-11-10 <b>Indication:</b> Unresectable or Metastatic Melanoma with a BRAF-Mutated Melanoma In Combination with Vemurafenib <b>Mechanism:</b> Kinase Inhibitor <b>Drug:</b> Cobimetinib Fumarate<br><b>Date of Approval:</b> 2015-11-10<br><b>Indication:</b> Unresectable or Metastatic Melanoma with a BRAF-Mutated Melanoma In Combination with Vemurafenib<br><b>Mechanism:</b> Kinase Inhibitor
2015-11-19 Ingenol Mebutate AK Describing response to a repeat course Other Cytotoxic Agent Cytotoxic Agent Cytotoxic Agent 82 <b>Drug:</b> Ingenol Mebutate <b>Date of Approval:</b> 2015-11-19 <b>Indication:</b> Describing response to a repeat course <b>Mechanism:</b> Cytotoxic Agent <b>Drug:</b> Ingenol Mebutate<br><b>Date of Approval:</b> 2015-11-19<br><b>Indication:</b> Describing response to a repeat course<br><b>Mechanism:</b> Cytotoxic Agent
2015-11-20 Trametinib Dimethyl Sulfoxide Melanoma Unresectable or Metastatic Melanoma with a BRAF-Mutated Melanoma In Combination with Dabrafenib Locally Advanced or Metastatic Kinase Inhibitor Kinase Inhibitor Targeted Therapy 83 <b>Drug:</b> Trametinib Dimethyl Sulfoxide <b>Date of Approval:</b> 2015-11-20 <b>Indication:</b> Unresectable or Metastatic Melanoma with a BRAF-Mutated Melanoma In Combination with Dabrafenib <b>Mechanism:</b> Kinase Inhibitor <b>Drug:</b> Trametinib Dimethyl Sulfoxide<br><b>Date of Approval:</b> 2015-11-20<br><b>Indication:</b> Unresectable or Metastatic Melanoma with a BRAF-Mutated Melanoma In Combination with Dabrafenib<br><b>Mechanism:</b> Kinase Inhibitor
2015-11-20 Dabrafenib Mesylate Melanoma Regular approval for Dab/Tram in advanced BRAF mutant melanoma Locally Advanced or Metastatic Kinase Inhibitor Kinase Inhibitor Targeted Therapy 84 <b>Drug:</b> Dabrafenib Mesylate <b>Date of Approval:</b> 2015-11-20 <b>Indication:</b> Regular approval for Dab/Tram in advanced BRAF mutant melanoma <b>Mechanism:</b> Kinase Inhibitor <b>Drug:</b> Dabrafenib Mesylate<br><b>Date of Approval:</b> 2015-11-20<br><b>Indication:</b> Regular approval for Dab/Tram in advanced BRAF mutant melanoma<br><b>Mechanism:</b> Kinase Inhibitor
2015-11-23 Nivolumab Melanoma Regular Approval for Unresectable or Metastatic BRAF-Wild Type Melanoma Locally Advanced or Metastatic PD-1 Ab PD-1 Targeted Antibody Immunotherapy 85 <b>Drug:</b> Nivolumab <b>Date of Approval:</b> 2015-11-23 <b>Indication:</b> Regular Approval for Unresectable or Metastatic BRAF-Wild Type Melanoma <b>Mechanism:</b> PD-1 Ab <b>Drug:</b> Nivolumab<br><b>Date of Approval:</b> 2015-11-23<br><b>Indication:</b> Regular Approval for Unresectable or Metastatic BRAF-Wild Type Melanoma<br><b>Mechanism:</b> PD-1 Ab
2015-12-18 Pembrolizumab Melanoma Unresectable or Metastatic Melanoma Locally Advanced or Metastatic PD-1 Ab PD-1 Targeted Antibody Immunotherapy 86 <b>Drug:</b> Pembrolizumab <b>Date of Approval:</b> 2015-12-18 <b>Indication:</b> Unresectable or Metastatic Melanoma <b>Mechanism:</b> PD-1 Ab <b>Drug:</b> Pembrolizumab<br><b>Date of Approval:</b> 2015-12-18<br><b>Indication:</b> Unresectable or Metastatic Melanoma<br><b>Mechanism:</b> PD-1 Ab
2015-12-18 Pembrolizumab Melanoma Removing language limiting the indication to disease progression following ipilimumab Other PD-1 Ab PD-1 Targeted Antibody Immunotherapy 87 <b>Drug:</b> Pembrolizumab <b>Date of Approval:</b> 2015-12-18 <b>Indication:</b> Removing language limiting the indication to disease progression following ipilimumab <b>Mechanism:</b> PD-1 Ab <b>Drug:</b> Pembrolizumab<br><b>Date of Approval:</b> 2015-12-18<br><b>Indication:</b> Removing language limiting the indication to disease progression following ipilimumab<br><b>Mechanism:</b> PD-1 Ab
2016-01-23 Nivolumab Melanoma Accelerated Approved for BRAF Mutant Unresectable or Metastatic Melanoma in the First Line Setting Locally Advanced or Metastatic PD-1 Ab PD-1 Targeted Antibody Immunotherapy 88 <b>Drug:</b> Nivolumab <b>Date of Approval:</b> 2016-01-23 <b>Indication:</b> Accelerated Approved for BRAF Mutant Unresectable or Metastatic Melanoma in the First Line Setting <b>Mechanism:</b> PD-1 Ab <b>Drug:</b> Nivolumab<br><b>Date of Approval:</b> 2016-01-23<br><b>Indication:</b> Accelerated Approved for BRAF Mutant Unresectable or Metastatic Melanoma in the First Line Setting<br><b>Mechanism:</b> PD-1 Ab
2016-01-23 Nivolumab Melanoma Accelerated approval of Ipi/Nivo Expansion for BRAF mutant as well as BRAF WT Other PD-1 Ab PD-1 Targeted Antibody Immunotherapy 89 <b>Drug:</b> Nivolumab <b>Date of Approval:</b> 2016-01-23 <b>Indication:</b> Accelerated approval of Ipi/Nivo Expansion for BRAF mutant as well as BRAF WT <b>Mechanism:</b> PD-1 Ab <b>Drug:</b> Nivolumab<br><b>Date of Approval:</b> 2016-01-23<br><b>Indication:</b> Accelerated approval of Ipi/Nivo Expansion for BRAF mutant as well as BRAF WT<br><b>Mechanism:</b> PD-1 Ab
2016-05-10 Aminolevulinic Acid Hydrochloride AK Actinic keratoses of mild-to-moderate severity on the face and scalp Other Phototoxic Phototoxic Agent Cytotoxic Agent 90 <b>Drug:</b> Aminolevulinic Acid Hydrochloride <b>Date of Approval:</b> 2016-05-10 <b>Indication:</b> Actinic keratoses of mild-to-moderate severity on the face and scalp <b>Mechanism:</b> Phototoxic <b>Drug:</b> Aminolevulinic Acid Hydrochloride<br><b>Date of Approval:</b> 2016-05-10<br><b>Indication:</b> Actinic keratoses of mild-to-moderate severity on the face and scalp<br><b>Mechanism:</b> Phototoxic
2016-09-13 Nivolumab Melanoma Flat Dosing for Melanoma, NSCLC and RCC Dosing Adjustment PD-1 Ab PD-1 Targeted Antibody Immunotherapy 91 <b>Drug:</b> Nivolumab <b>Date of Approval:</b> 2016-09-13 <b>Indication:</b> Flat Dosing for Melanoma, NSCLC and RCC <b>Mechanism:</b> PD-1 Ab <b>Drug:</b> Nivolumab<br><b>Date of Approval:</b> 2016-09-13<br><b>Indication:</b> Flat Dosing for Melanoma, NSCLC and RCC<br><b>Mechanism:</b> PD-1 Ab
2016-09-13 Nivolumab Melanoma Flat Dosing for Melanoma, NSCLC and RCC Dosing Adjustment PD-1 Ab PD-1 Targeted Antibody Immunotherapy 92 <b>Drug:</b> Nivolumab <b>Date of Approval:</b> 2016-09-13 <b>Indication:</b> Flat Dosing for Melanoma, NSCLC and RCC <b>Mechanism:</b> PD-1 Ab <b>Drug:</b> Nivolumab<br><b>Date of Approval:</b> 2016-09-13<br><b>Indication:</b> Flat Dosing for Melanoma, NSCLC and RCC<br><b>Mechanism:</b> PD-1 Ab
2017-03-23 Avelumab MCC Metastatic Merkel Cell Carcinoma Metastatic PD-L1 Ab PD-L1 Targeted Antibody Immunotherapy 93 <b>Drug:</b> Avelumab <b>Date of Approval:</b> 2017-03-23 <b>Indication:</b> Metastatic Merkel Cell Carcinoma <b>Mechanism:</b> PD-L1 Ab <b>Drug:</b> Avelumab<br><b>Date of Approval:</b> 2017-03-23<br><b>Indication:</b> Metastatic Merkel Cell Carcinoma<br><b>Mechanism:</b> PD-L1 Ab
2017-05-17 Pembrolizumab Melanoma Flat Dosing of 200 mg q3 weeks in melanoma Dosing Adjustment PD-1 Ab PD-1 Targeted Antibody Immunotherapy 94 <b>Drug:</b> Pembrolizumab <b>Date of Approval:</b> 2017-05-17 <b>Indication:</b> Flat Dosing of 200 mg q3 weeks in melanoma <b>Mechanism:</b> PD-1 Ab <b>Drug:</b> Pembrolizumab<br><b>Date of Approval:</b> 2017-05-17<br><b>Indication:</b> Flat Dosing of 200 mg q3 weeks in melanoma<br><b>Mechanism:</b> PD-1 Ab
2017-05-23 Pembrolizumab Agnostic Unresectable or Metastatic, Microsatellite Instability-High or Mismatch Repair Deficient Solid Tumors Locally Advanced or Metastatic PD-1 Ab PD-1 Targeted Antibody Immunotherapy 95 <b>Drug:</b> Pembrolizumab <b>Date of Approval:</b> 2017-05-23 <b>Indication:</b> Unresectable or Metastatic, Microsatellite Instability-High or Mismatch Repair Deficient Solid Tumors <b>Mechanism:</b> PD-1 Ab <b>Drug:</b> Pembrolizumab<br><b>Date of Approval:</b> 2017-05-23<br><b>Indication:</b> Unresectable or Metastatic, Microsatellite Instability-High or Mismatch Repair Deficient Solid Tumors<br><b>Mechanism:</b> PD-1 Ab
2017-07-21 Ipilimumab Melanoma Unresectable or Metastatic Melanoma - patients 12 years and older Locally Advanced or Metastatic CTLA-4 Ab CTLA-4 Targeted Antibody Immunotherapy 96 <b>Drug:</b> Ipilimumab <b>Date of Approval:</b> 2017-07-21 <b>Indication:</b> Unresectable or Metastatic Melanoma - patients 12 years and older <b>Mechanism:</b> CTLA-4 Ab <b>Drug:</b> Ipilimumab<br><b>Date of Approval:</b> 2017-07-21<br><b>Indication:</b> Unresectable or Metastatic Melanoma - patients 12 years and older<br><b>Mechanism:</b> CTLA-4 Ab
2017-11-09 Brentuximab Vedotin CTCL CD30+ MF and pcALCL in the second line Refractory CD30 Ab CD30 Targeted Antibody Targeted Therapy 97 <b>Drug:</b> Brentuximab Vedotin <b>Date of Approval:</b> 2017-11-09 <b>Indication:</b> CD30+ MF and pcALCL in the second line <b>Mechanism:</b> CD30 Ab <b>Drug:</b> Brentuximab Vedotin<br><b>Date of Approval:</b> 2017-11-09<br><b>Indication:</b> CD30+ MF and pcALCL in the second line<br><b>Mechanism:</b> CD30 Ab
2017-12-20 Nivolumab Melanoma Regular Approval for Adjuvant Melanoma Adjuvant PD-1 Ab PD-1 Targeted Antibody Immunotherapy 98 <b>Drug:</b> Nivolumab <b>Date of Approval:</b> 2017-12-20 <b>Indication:</b> Regular Approval for Adjuvant Melanoma <b>Mechanism:</b> PD-1 Ab <b>Drug:</b> Nivolumab<br><b>Date of Approval:</b> 2017-12-20<br><b>Indication:</b> Regular Approval for Adjuvant Melanoma<br><b>Mechanism:</b> PD-1 Ab
2018-01-09 Nivolumab Melanoma Updates infusion from 60 to 30 minutes Other PD-1 Ab PD-1 Targeted Antibody Immunotherapy 99 <b>Drug:</b> Nivolumab <b>Date of Approval:</b> 2018-01-09 <b>Indication:</b> Updates infusion from 60 to 30 minutes <b>Mechanism:</b> PD-1 Ab <b>Drug:</b> Nivolumab<br><b>Date of Approval:</b> 2018-01-09<br><b>Indication:</b> Updates infusion from 60 to 30 minutes<br><b>Mechanism:</b> PD-1 Ab
2018-01-26 Cobimetinib Fumarate Melanoma Updates label to include OS data Other Kinase Inhibitor Kinase Inhibitor Targeted Therapy 100 <b>Drug:</b> Cobimetinib Fumarate <b>Date of Approval:</b> 2018-01-26 <b>Indication:</b> Updates label to include OS data <b>Mechanism:</b> Kinase Inhibitor <b>Drug:</b> Cobimetinib Fumarate<br><b>Date of Approval:</b> 2018-01-26<br><b>Indication:</b> Updates label to include OS data<br><b>Mechanism:</b> Kinase Inhibitor
2018-03-05 Nivolumab Melanoma Every 4 Week Dosing for Advanced Melanoma Dosing Adjustment PD-1 Ab PD-1 Targeted Antibody Immunotherapy 101 <b>Drug:</b> Nivolumab <b>Date of Approval:</b> 2018-03-05 <b>Indication:</b> Every 4 Week Dosing for Advanced Melanoma <b>Mechanism:</b> PD-1 Ab <b>Drug:</b> Nivolumab<br><b>Date of Approval:</b> 2018-03-05<br><b>Indication:</b> Every 4 Week Dosing for Advanced Melanoma<br><b>Mechanism:</b> PD-1 Ab
2018-03-05 Nivolumab Melanoma Every 4 week dosing in Adjuvant Melanoma Adjuvant PD-1 Ab PD-1 Targeted Antibody Immunotherapy 102 <b>Drug:</b> Nivolumab <b>Date of Approval:</b> 2018-03-05 <b>Indication:</b> Every 4 week dosing in Adjuvant Melanoma <b>Mechanism:</b> PD-1 Ab <b>Drug:</b> Nivolumab<br><b>Date of Approval:</b> 2018-03-05<br><b>Indication:</b> Every 4 week dosing in Adjuvant Melanoma<br><b>Mechanism:</b> PD-1 Ab
2018-03-05 Nivolumab Melanoma Updates infusion from 60 to 30 minutes in adjuvant Melanoma Adjuvant PD-1 Ab PD-1 Targeted Antibody Immunotherapy 103 <b>Drug:</b> Nivolumab <b>Date of Approval:</b> 2018-03-05 <b>Indication:</b> Updates infusion from 60 to 30 minutes in adjuvant Melanoma <b>Mechanism:</b> PD-1 Ab <b>Drug:</b> Nivolumab<br><b>Date of Approval:</b> 2018-03-05<br><b>Indication:</b> Updates infusion from 60 to 30 minutes in adjuvant Melanoma<br><b>Mechanism:</b> PD-1 Ab
2018-03-06 Aminolevulinic Acid Hydrochloride AK Minimally to moderately thick Actinic Keratosis of the upper extremities Other Phototoxic Phototoxic Agent Cytotoxic Agent 104 <b>Drug:</b> Aminolevulinic Acid Hydrochloride <b>Date of Approval:</b> 2018-03-06 <b>Indication:</b> Minimally to moderately thick Actinic Keratosis of the upper extremities <b>Mechanism:</b> Phototoxic <b>Drug:</b> Aminolevulinic Acid Hydrochloride<br><b>Date of Approval:</b> 2018-03-06<br><b>Indication:</b> Minimally to moderately thick Actinic Keratosis of the upper extremities<br><b>Mechanism:</b> Phototoxic
2018-04-30 Trametinib Dimethyl Sulfoxide Melanoma Adjuvant BRAF Mutant Melanoma In Combination with Dabrafenib Adjuvant Kinase Inhibitor Kinase Inhibitor Targeted Therapy 105 <b>Drug:</b> Trametinib Dimethyl Sulfoxide <b>Date of Approval:</b> 2018-04-30 <b>Indication:</b> Adjuvant BRAF Mutant Melanoma In Combination with Dabrafenib <b>Mechanism:</b> Kinase Inhibitor <b>Drug:</b> Trametinib Dimethyl Sulfoxide<br><b>Date of Approval:</b> 2018-04-30<br><b>Indication:</b> Adjuvant BRAF Mutant Melanoma In Combination with Dabrafenib<br><b>Mechanism:</b> Kinase Inhibitor
2018-04-30 Dabrafenib Mesylate Melanoma Adjuvant BRAF Mutant Melanoma In Combination with Trametinib Adjuvant Kinase Inhibitor Kinase Inhibitor Targeted Therapy 106 <b>Drug:</b> Dabrafenib Mesylate <b>Date of Approval:</b> 2018-04-30 <b>Indication:</b> Adjuvant BRAF Mutant Melanoma In Combination with Trametinib <b>Mechanism:</b> Kinase Inhibitor <b>Drug:</b> Dabrafenib Mesylate<br><b>Date of Approval:</b> 2018-04-30<br><b>Indication:</b> Adjuvant BRAF Mutant Melanoma In Combination with Trametinib<br><b>Mechanism:</b> Kinase Inhibitor
2018-06-27 Encorafenib Melanoma Regular Approval for use in combination with binimetinib for advanced BRAF mutant melanoma Locally Advanced or Metastatic Kinase Inhibitor Kinase Inhibitor Targeted Therapy 107 <b>Drug:</b> Encorafenib <b>Date of Approval:</b> 2018-06-27 <b>Indication:</b> Regular Approval for use in combination with binimetinib for advanced BRAF mutant melanoma <b>Mechanism:</b> Kinase Inhibitor <b>Drug:</b> Encorafenib<br><b>Date of Approval:</b> 2018-06-27<br><b>Indication:</b> Regular Approval for use in combination with binimetinib for advanced BRAF mutant melanoma<br><b>Mechanism:</b> Kinase Inhibitor
2018-06-27 Binimetinib Melanoma Unresectable or Metastatic BRAF-Mutated Melanoma In Combination with Encorafenib Locally Advanced or Metastatic Kinase Inhibitor Kinase Inhibitor Targeted Therapy 108 <b>Drug:</b> Binimetinib <b>Date of Approval:</b> 2018-06-27 <b>Indication:</b> Unresectable or Metastatic BRAF-Mutated Melanoma In Combination with Encorafenib <b>Mechanism:</b> Kinase Inhibitor <b>Drug:</b> Binimetinib<br><b>Date of Approval:</b> 2018-06-27<br><b>Indication:</b> Unresectable or Metastatic BRAF-Mutated Melanoma In Combination with Encorafenib<br><b>Mechanism:</b> Kinase Inhibitor
2018-08-08 Mogamulizumab-Kpkc CTCL Relapsed/Refractory Mycosis Fungoides or Sezary Syndrome - Second Line Refractory CCR4 Ab CCR4 Targeted Antibody & ADCC Inducer Immunotherapy 109 <b>Drug:</b> Mogamulizumab-Kpkc <b>Date of Approval:</b> 2018-08-08 <b>Indication:</b> Relapsed/Refractory Mycosis Fungoides or Sezary Syndrome - Second Line <b>Mechanism:</b> CCR4 Ab <b>Drug:</b> Mogamulizumab-Kpkc<br><b>Date of Approval:</b> 2018-08-08<br><b>Indication:</b> Relapsed/Refractory Mycosis Fungoides or Sezary Syndrome - Second Line<br><b>Mechanism:</b> CCR4 Ab
2018-09-28 Cemiplimab-Rwlc SCC Locally Advanced or Metastatic Squamous Cell Carcinoma Locally Advanced or Metastatic PD-1 Ab PD-1 Targeted Antibody Immunotherapy 110 <b>Drug:</b> Cemiplimab-Rwlc <b>Date of Approval:</b> 2018-09-28 <b>Indication:</b> Locally Advanced or Metastatic Squamous Cell Carcinoma <b>Mechanism:</b> PD-1 Ab <b>Drug:</b> Cemiplimab-Rwlc<br><b>Date of Approval:</b> 2018-09-28<br><b>Indication:</b> Locally Advanced or Metastatic Squamous Cell Carcinoma<br><b>Mechanism:</b> PD-1 Ab
2018-12-19 Pembrolizumab MCC Locally Advanced or Metastatic Merkel Cell Carcinoma Locally Advanced or Metastatic PD-1 Ab PD-1 Targeted Antibody Immunotherapy 111 <b>Drug:</b> Pembrolizumab <b>Date of Approval:</b> 2018-12-19 <b>Indication:</b> Locally Advanced or Metastatic Merkel Cell Carcinoma <b>Mechanism:</b> PD-1 Ab <b>Drug:</b> Pembrolizumab<br><b>Date of Approval:</b> 2018-12-19<br><b>Indication:</b> Locally Advanced or Metastatic Merkel Cell Carcinoma<br><b>Mechanism:</b> PD-1 Ab
2019-01-18 Vismodegib BCC To allow for treatment interruptions of up to 8 weeks for intolerable AEs Other Smoothened Inhibitor Smoothened Inhibitor Targeted Therapy 112 <b>Drug:</b> Vismodegib <b>Date of Approval:</b> 2019-01-18 <b>Indication:</b> To allow for treatment interruptions of up to 8 weeks for intolerable AEs <b>Mechanism:</b> Smoothened Inhibitor <b>Drug:</b> Vismodegib<br><b>Date of Approval:</b> 2019-01-18<br><b>Indication:</b> To allow for treatment interruptions of up to 8 weeks for intolerable AEs<br><b>Mechanism:</b> Smoothened Inhibitor
2019-02-15 Pembrolizumab Melanoma Adjuvant Melanoma Adjuvant PD-1 Ab PD-1 Targeted Antibody Immunotherapy 113 <b>Drug:</b> Pembrolizumab <b>Date of Approval:</b> 2019-02-15 <b>Indication:</b> Adjuvant Melanoma <b>Mechanism:</b> PD-1 Ab <b>Drug:</b> Pembrolizumab<br><b>Date of Approval:</b> 2019-02-15<br><b>Indication:</b> Adjuvant Melanoma<br><b>Mechanism:</b> PD-1 Ab
2019-03-07 Nivolumab Melanoma Conversion to Regular Approval for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma Locally Advanced or Metastatic PD-1 Ab PD-1 Targeted Antibody Immunotherapy 114 <b>Drug:</b> Nivolumab <b>Date of Approval:</b> 2019-03-07 <b>Indication:</b> Conversion to Regular Approval for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma <b>Mechanism:</b> PD-1 Ab <b>Drug:</b> Nivolumab<br><b>Date of Approval:</b> 2019-03-07<br><b>Indication:</b> Conversion to Regular Approval for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma<br><b>Mechanism:</b> PD-1 Ab
2019-03-07 Nivolumab Melanoma Conversion to Regular Approval of OPDIVO, in combination with ipilimumab, for the treatment of patients with unresectable or metastatic melanoma Locally Advanced or Metastatic PD-1 Ab PD-1 Targeted Antibody Immunotherapy 115 <b>Drug:</b> Nivolumab <b>Date of Approval:</b> 2019-03-07 <b>Indication:</b> Conversion to Regular Approval of OPDIVO, in combination with ipilimumab, for the treatment of patients with unresectable or metastatic melanoma <b>Mechanism:</b> PD-1 Ab <b>Drug:</b> Nivolumab<br><b>Date of Approval:</b> 2019-03-07<br><b>Indication:</b> Conversion to Regular Approval of OPDIVO, in combination with ipilimumab, for the treatment of patients with unresectable or metastatic melanoma<br><b>Mechanism:</b> PD-1 Ab
2019-10-06 Trametinib Dimethyl Sulfoxide Melanoma Updating results in subjects with brain metastases Other Kinase Inhibitor Kinase Inhibitor Targeted Therapy 116 <b>Drug:</b> Trametinib Dimethyl Sulfoxide <b>Date of Approval:</b> 2019-10-06 <b>Indication:</b> Updating results in subjects with brain metastases <b>Mechanism:</b> Kinase Inhibitor <b>Drug:</b> Trametinib Dimethyl Sulfoxide<br><b>Date of Approval:</b> 2019-10-06<br><b>Indication:</b> Updating results in subjects with brain metastases<br><b>Mechanism:</b> Kinase Inhibitor
2019-10-06 Dabrafenib Mesylate Melanoma Updates label in regards to brain mets for melanoma Other Kinase Inhibitor Kinase Inhibitor Targeted Therapy 117 <b>Drug:</b> Dabrafenib Mesylate <b>Date of Approval:</b> 2019-10-06 <b>Indication:</b> Updates label in regards to brain mets for melanoma <b>Mechanism:</b> Kinase Inhibitor <b>Drug:</b> Dabrafenib Mesylate<br><b>Date of Approval:</b> 2019-10-06<br><b>Indication:</b> Updates label in regards to brain mets for melanoma<br><b>Mechanism:</b> Kinase Inhibitor
2020-04-28 Pembrolizumab Melanoma Every 6 weeks dosing in Melanoma Dosing Adjustment PD-1 Ab PD-1 Targeted Antibody Immunotherapy 118 <b>Drug:</b> Pembrolizumab <b>Date of Approval:</b> 2020-04-28 <b>Indication:</b> Every 6 weeks dosing in Melanoma <b>Mechanism:</b> PD-1 Ab <b>Drug:</b> Pembrolizumab<br><b>Date of Approval:</b> 2020-04-28<br><b>Indication:</b> Every 6 weeks dosing in Melanoma<br><b>Mechanism:</b> PD-1 Ab
2020-04-28 Pembrolizumab MCC Every 6 weeks dosing in Merkel Cell Carcinoma Dosing Adjustment PD-1 Ab PD-1 Targeted Antibody Immunotherapy 119 <b>Drug:</b> Pembrolizumab <b>Date of Approval:</b> 2020-04-28 <b>Indication:</b> Every 6 weeks dosing in Merkel Cell Carcinoma <b>Mechanism:</b> PD-1 Ab <b>Drug:</b> Pembrolizumab<br><b>Date of Approval:</b> 2020-04-28<br><b>Indication:</b> Every 6 weeks dosing in Merkel Cell Carcinoma<br><b>Mechanism:</b> PD-1 Ab
2020-04-28 Pembrolizumab Agnostic Every 6 weeks dosing in MSI-H tumors Dosing Adjustment PD-1 Ab PD-1 Targeted Antibody Immunotherapy 120 <b>Drug:</b> Pembrolizumab <b>Date of Approval:</b> 2020-04-28 <b>Indication:</b> Every 6 weeks dosing in MSI-H tumors <b>Mechanism:</b> PD-1 Ab <b>Drug:</b> Pembrolizumab<br><b>Date of Approval:</b> 2020-04-28<br><b>Indication:</b> Every 6 weeks dosing in MSI-H tumors<br><b>Mechanism:</b> PD-1 Ab
2020-05-14 Pomalidomide KS Treatment of adult patients with AIDS-related Kaposi sarcoma Other Immunomodulatory Cereblon Inhibitor Imid 121 <b>Drug:</b> Pomalidomide <b>Date of Approval:</b> 2020-05-14 <b>Indication:</b> Treatment of adult patients with AIDS-related Kaposi sarcoma <b>Mechanism:</b> Immunomodulatory <b>Drug:</b> Pomalidomide<br><b>Date of Approval:</b> 2020-05-14<br><b>Indication:</b> Treatment of adult patients with AIDS-related Kaposi sarcoma<br><b>Mechanism:</b> Immunomodulatory
2020-05-14 Pomalidomide KS Treatment of Kaposi’s Sarcoma in patients who are HIV-negative Other Immunomodulatory Cereblon Inhibitor Imid 122 <b>Drug:</b> Pomalidomide <b>Date of Approval:</b> 2020-05-14 <b>Indication:</b> Treatment of Kaposi’s Sarcoma in patients who are HIV-negative <b>Mechanism:</b> Immunomodulatory <b>Drug:</b> Pomalidomide<br><b>Date of Approval:</b> 2020-05-14<br><b>Indication:</b> Treatment of Kaposi’s Sarcoma in patients who are HIV-negative<br><b>Mechanism:</b> Immunomodulatory
2020-06-16 Pembrolizumab Agnostic Tumor Mutation Burden-High solid tumors Other PD-1 Ab PD-1 Targeted Antibody Immunotherapy 123 <b>Drug:</b> Pembrolizumab <b>Date of Approval:</b> 2020-06-16 <b>Indication:</b> Tumor Mutation Burden-High solid tumors <b>Mechanism:</b> PD-1 Ab <b>Drug:</b> Pembrolizumab<br><b>Date of Approval:</b> 2020-06-16<br><b>Indication:</b> Tumor Mutation Burden-High solid tumors<br><b>Mechanism:</b> PD-1 Ab
2020-06-16 Pembrolizumab Agnostic Every 6 weeks dosing in TMB-H tumors Dosing Adjustment PD-1 Ab PD-1 Targeted Antibody Immunotherapy 124 <b>Drug:</b> Pembrolizumab <b>Date of Approval:</b> 2020-06-16 <b>Indication:</b> Every 6 weeks dosing in TMB-H tumors <b>Mechanism:</b> PD-1 Ab <b>Drug:</b> Pembrolizumab<br><b>Date of Approval:</b> 2020-06-16<br><b>Indication:</b> Every 6 weeks dosing in TMB-H tumors<br><b>Mechanism:</b> PD-1 Ab
2020-06-24 Pembrolizumab SCC r/mCSCC Locally Advanced or Metastatic PD-1 Ab PD-1 Targeted Antibody Immunotherapy 125 <b>Drug:</b> Pembrolizumab <b>Date of Approval:</b> 2020-06-24 <b>Indication:</b> r/mCSCC <b>Mechanism:</b> PD-1 Ab <b>Drug:</b> Pembrolizumab<br><b>Date of Approval:</b> 2020-06-24<br><b>Indication:</b> r/mCSCC<br><b>Mechanism:</b> PD-1 Ab
2020-06-24 Pembrolizumab SCC Every 6 weeks dosing for CSCC Dosing Adjustment PD-1 Ab PD-1 Targeted Antibody Immunotherapy 126 <b>Drug:</b> Pembrolizumab <b>Date of Approval:</b> 2020-06-24 <b>Indication:</b> Every 6 weeks dosing for CSCC <b>Mechanism:</b> PD-1 Ab <b>Drug:</b> Pembrolizumab<br><b>Date of Approval:</b> 2020-06-24<br><b>Indication:</b> Every 6 weeks dosing for CSCC<br><b>Mechanism:</b> PD-1 Ab
2020-07-30 Atezolizumab Melanoma Unresectable or metastatic BRAF-mutated melanoma in combination with cobimetinib and vemurafenib Locally Advanced or Metastatic PD-L1 Ab PD-L1 Targeted Antibody Immunotherapy 127 <b>Drug:</b> Atezolizumab <b>Date of Approval:</b> 2020-07-30 <b>Indication:</b> Unresectable or metastatic BRAF-mutated melanoma in combination with cobimetinib and vemurafenib <b>Mechanism:</b> PD-L1 Ab <b>Drug:</b> Atezolizumab<br><b>Date of Approval:</b> 2020-07-30<br><b>Indication:</b> Unresectable or metastatic BRAF-mutated melanoma in combination with cobimetinib and vemurafenib<br><b>Mechanism:</b> PD-L1 Ab
2020-12-14 Tirbanibulin AK Actinic keratosis of the face or scalp Other Microtubule Inhibitor Microtubule Inhibitor Cytotoxic Agent 128 <b>Drug:</b> Tirbanibulin <b>Date of Approval:</b> 2020-12-14 <b>Indication:</b> Actinic keratosis of the face or scalp <b>Mechanism:</b> Microtubule Inhibitor <b>Drug:</b> Tirbanibulin<br><b>Date of Approval:</b> 2020-12-14<br><b>Indication:</b> Actinic keratosis of the face or scalp<br><b>Mechanism:</b> Microtubule Inhibitor
2021-02-09 Cemiplimab-Rwlc BCC Locally Advanced Basal Cell Carcinoma Locally Advanced PD-1 Ab PD-1 Targeted Antibody Immunotherapy 129 <b>Drug:</b> Cemiplimab-Rwlc <b>Date of Approval:</b> 2021-02-09 <b>Indication:</b> Locally Advanced Basal Cell Carcinoma <b>Mechanism:</b> PD-1 Ab <b>Drug:</b> Cemiplimab-Rwlc<br><b>Date of Approval:</b> 2021-02-09<br><b>Indication:</b> Locally Advanced Basal Cell Carcinoma<br><b>Mechanism:</b> PD-1 Ab
2021-02-09 Cemiplimab-Rwlc BCC Metastatic Basal Cell Carcinoma Metastatic PD-1 Ab PD-1 Targeted Antibody Immunotherapy 130 <b>Drug:</b> Cemiplimab-Rwlc <b>Date of Approval:</b> 2021-02-09 <b>Indication:</b> Metastatic Basal Cell Carcinoma <b>Mechanism:</b> PD-1 Ab <b>Drug:</b> Cemiplimab-Rwlc<br><b>Date of Approval:</b> 2021-02-09<br><b>Indication:</b> Metastatic Basal Cell Carcinoma<br><b>Mechanism:</b> PD-1 Ab
2021-07-01 Pembrolizumab SCC laCSCC Locally Advanced PD-1 Ab PD-1 Targeted Antibody Immunotherapy 131 <b>Drug:</b> Pembrolizumab <b>Date of Approval:</b> 2021-07-01 <b>Indication:</b> laCSCC <b>Mechanism:</b> PD-1 Ab <b>Drug:</b> Pembrolizumab<br><b>Date of Approval:</b> 2021-07-01<br><b>Indication:</b> laCSCC<br><b>Mechanism:</b> PD-1 Ab
2021-12-03 Pembrolizumab Melanoma Adjuvant Stage IIB and IIC Melanoma Adjuvant PD-1 Ab PD-1 Targeted Antibody Immunotherapy 132 <b>Drug:</b> Pembrolizumab <b>Date of Approval:</b> 2021-12-03 <b>Indication:</b> Adjuvant Stage IIB and IIC Melanoma <b>Mechanism:</b> PD-1 Ab <b>Drug:</b> Pembrolizumab<br><b>Date of Approval:</b> 2021-12-03<br><b>Indication:</b> Adjuvant Stage IIB and IIC Melanoma<br><b>Mechanism:</b> PD-1 Ab
2022-01-25 Tebentafusp-Tebn Melanoma HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma Locally Advanced or Metastatic Bispecific Antibody Bispecific gp100 peptide-HLA-A*02:01 directed T cell receptor CD3 T cell engager Immunotherapy 133 <b>Drug:</b> Tebentafusp-Tebn <b>Date of Approval:</b> 2022-01-25 <b>Indication:</b> HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma <b>Mechanism:</b> Bispecific Antibody <b>Drug:</b> Tebentafusp-Tebn<br><b>Date of Approval:</b> 2022-01-25<br><b>Indication:</b> HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma<br><b>Mechanism:</b> Bispecific Antibody
2022-03-18 Relatlimab-Rmbw Melanoma Unresectable or Metastatic Melanoma Locally Advanced or Metastatic LAG-3 Ab LAG-3 Targeted Antibody Immunotherapy 134 <b>Drug:</b> Relatlimab-Rmbw <b>Date of Approval:</b> 2022-03-18 <b>Indication:</b> Unresectable or Metastatic Melanoma <b>Mechanism:</b> LAG-3 Ab <b>Drug:</b> Relatlimab-Rmbw<br><b>Date of Approval:</b> 2022-03-18<br><b>Indication:</b> Unresectable or Metastatic Melanoma<br><b>Mechanism:</b> LAG-3 Ab

fda_approval_timeliner_plot()

When used in isolation

fda_approval_timeliner_plot(
  .startbuffer = 3200,
  .endbuffer = 2000,
  .geomtextsize = 3.5,
  .legendtextsize = 8,
  .hoverlabeltextsize = 14,
  .legend = TRUE,
  .xaxistickfontsize = 14
)

When used in conjuction with fda_approval_timeline_df()

skincancerRx_data |> 
  filter(Dz == "Melanoma") |> 
  fda_approval_timeliner_df() |> 
  skincancerRx::fda_approval_timeliner_plot(
    .title = "<b>FDA Approvals for Melanoma<b>",
    .startbuffer = 1000,
    .endbuffer = 1400,
    .geomtextsize = 4,
    .legendtextsize = 2,
    .hoverlabeltextsize = 14,
    .legend = FALSE,
    .xaxistickfontsize = 14
)

fda_approval_timeseries_df()

fda_approval_timeseries_df() |> 
    kable() %>%
    kable_styling(bootstrap_options = c("striped","hover"),
                  fixed_thead = T) %>%
    scroll_box(height = "400px",
               width = "100%")
date name Dz Indication_brief Indication_short Mechanism Mechanism_long Mechanistic_Class y
1949-03-15 MECHLORETHAMINE HYDROCHLORIDE CTCL Mycosis Fungoides Other Alkylating Agent Alkylating Agent Cytotoxic Agent 1
1950-06-13 CORTISONE ACETATE CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 2
1950-12-04 CORTISONE ACETATE CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 3
1952-12-15 HYDROCORTISONE CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 4
1953-12-07 METHOTREXATE SODIUM CTCL Mycosis Fungoides Other Antimetabolite Antimetabolite Cytotoxic Agent 5
1955-02-21 PREDNISONE CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 6
1955-04-27 HYDROCORTISONE SODIUM SUCCINATE CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 7
1955-06-21 PREDNISOLONE CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 8
1957-10-24 METHYLPREDNISOLONE CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 9
1957-12-03 TRIAMCINOLONE CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 10
1958-10-30 DEXAMETHASONE CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 11
1959-03-12 TRIAMCINOLONE DIACETATE CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 12
1959-05-18 METHYLPREDNISOLONE SODIUM SUCCINATE CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 13
1959-05-27 METHYLPREDNISOLONE ACETATE CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 14
1959-08-10 METHOTREXATE SODIUM CTCL Mycosis Fungoides Other Antimetabolite Antimetabolite Cytotoxic Agent 15
1959-10-06 DEXAMETHASONE SODIUM PHOSPHATE CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 16
1959-11-16 CYCLOPHOSPHAMIDE CTCL Mycosis Fungoides Other Alkylating Agent Alkylating Agent Cytotoxic Agent 17
1959-11-16 CYCLOPHOSPHAMIDE CTCL Mycosis Fungoides Other Alkylating Agent Alkylating Agent Cytotoxic Agent 18
1960-06-21 METHYLPREDNISOLONE ACETATE CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 19
1960-07-07 DEXAMETHASONE CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 20
1961-04-17 BETAMETHASONE CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 21
1961-09-05 TRIAMCINOLONE DIACETATE CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 22
1965-02-01 TRIAMCINOLONE ACETONIDE CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 23
1965-03-03 BETAMETHASONE ACETATE CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 24
1965-11-25 VINBLASTINE SULFATE CTCL Mycosis Fungoides Other Microtubule Inhibitor Microtubule Inhibitor Cytotoxic Agent 25
1965-11-25 VINBLASTINE SULFATE KS Kaposi's Sarcoma Other Microtubule Inhibitor Microtubule Inhibitor Cytotoxic Agent 26
1967-12-07 HYDROXYUREA Melanoma Melanoma Other Antimetabolite Antimetabolite Cytotoxic Agent 27
1970-07-29 FLUOROURACIL AK Multiple Actinic Keratoses Other Antimetabolite Antimetabolite Cytotoxic Agent 28
1971-08-06 FLUOROURACIL AK Actinic Keratoses Other Antimetabolite Antimetabolite Cytotoxic Agent 29
1975-05-27 DACARBAZINE Melanoma Metastatic Malignant Melanoma Metastatic Alkylating Agent Alkylating Agent Cytotoxic Agent 30
1975-06-30 FLUOROURACIL BCC Superficial Basal Cell Carcinoma Other Antimetabolite Antimetabolite Cytotoxic Agent 31
1986-05-28 PREDNISOLONE SODIUM PHOSPHATE CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 32
1988-03-23 METHOXSALEN CTCL Refractory Cutaneous T-Cell Lymphoma Refractory Phototoxic Phototoxic Agent Cytotoxic Agent 33
1988-11-21 INTERFERON ALFA-2B KS AIDS-Related Kaposi's Sarcoma Other Cytokine Cytokine Immunotherapy 34
1988-11-21 INTERFERON ALFA-2A KS AIDS-Related Kaposi's Sarcoma Other Cytokine Cytokine Immunotherapy 35
1995-11-17 DOXORUBICIN HYDROCHLORIDE KS Accelerated Approval for Refractory AIDS-Related Kaposi's Sarcoma Refractory Topoisomerase Inhibitor Topoisomerase Inhibitor Cytotoxic Agent 36
1995-12-05 INTERFERON ALFA-2B Melanoma Adjuvant Melanoma Adjuvant Cytokine Cytokine Immunotherapy 37
1996-04-08 DAUNORUBICIN CITRATE KS HIV-associated Kaposi's Sarcoma - First Line Other Topoisomerase Inhibitor Topoisomerase Inhibitor Cytotoxic Agent 38
1997-08-04 PACLITAXEL KS AIDS-Related Kaposi's Sarcoma - Second Line Refractory Microtubule Stabilizer Microtubule Stabilizer Cytotoxic Agent 39
1998-01-09 ALDESLEUKIN Melanoma Metastatic Melanoma Metastatic Cytokine Cytokine Immunotherapy 40
1998-12-17 PREDNISOLONE SODIUM PHOSPHATE CTCL Expansion to include pediatric populations Other Glucocorticoid Glucocorticoid Glucocorticoid 41
1999-02-02 ALITRETINOIN KS AIDS-Related Kaposi's Sarcoma - Cutaneous Lesions Only Other Retinoid Retinoid Retinoid 42
1999-02-05 DENILEUKIN DIFTITOX CTCL Accelerated Approval for Persistent or Recurrent CD25+ Cutaneous T-Cell Lymphoma Other Cytokine-Cytotoxin Cytokine-Cytotoxin Cytotoxic Agent 43
1999-02-25 METHOXSALEN CTCL Refractory Cutaneous T-Cell Lymphoma Refractory Phototoxic Phototoxic Agent Cytotoxic Agent 44
1999-12-03 AMINOLEVULINIC ACID HYDROCHLORIDE AK Non-Hyperkeratotic Actinic Keratoses of the Face or Scalp Other Phototoxic Phototoxic Agent Cytotoxic Agent 45
1999-12-29 BEXAROTENE CTCL Refractory Cutaneous T-Cell Lymphoma Refractory Retinoid Retinoid Retinoid 46
2000-06-28 BEXAROTENE CTCL Refractory Stage IA and IB Cutaneous T-Cell Lymphoma Refractory Retinoid Retinoid Retinoid 47
2000-10-16 DICLOFENAC SODIUM AK Actinic Keratoses Other NSAID NSAID NSAID 48
2000-10-27 FLUOROURACIL AK Multiple Actinic Keratoses of the Face and Anterior Scalp Other Antimetabolite Antimetabolite Cytotoxic Agent 49
2004-03-02 IMIQUIMOD AK Nonhypertrophic Actinic Keratoses on the Face or Scalp Other TLR Agonist TLR Agonist Immunotherapy 50
2004-07-14 IMIQUIMOD BCC Superficial Basal Cell Carcinoma Other TLR Agonist TLR Agonist Immunotherapy 51
2004-07-27 METHYL AMINOLEVULINATE HYDROCHLORIDE AK Non-Keratotic Actinic Keratoses of the Face and Scalp Other Phototoxic Phototoxic Agent Cytotoxic Agent 52
2006-06-01 PREDNISOLONE SODIUM PHOSPHATE CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 53
2006-10-06 VORINOSTAT CTCL Refractory Cutaneous T-Cell Lymphoma Refractory HDAC Inhibitor HDAC Inhibitor Targeted Therapy 54
2006-10-19 IMATINIB MESYLATE DFSP Unresectable, Recurrent and/or Metastatic Dermatofibrosarcoma Protuberans Locally Advanced or Metastatic Kinase Inhibitor Kinase Inhibitor Targeted Therapy 55
2008-01-17 PREDNISOLONE ACETATE CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 56
2008-06-10 DOXORUBICIN HYDROCHLORIDE KS Regular Aprroval for Refractory AIDS-Related Kaposi's Sarcoma Refractory Topoisomerase Inhibitor Topoisomerase Inhibitor Cytotoxic Agent 57
2008-06-16 TRIAMCINOLONE ACETONIDE CTCL Mycosis Fungoides Other Glucocorticoid Glucocorticoid Glucocorticoid 58
2008-06-26 METHYL AMINOLEVULINATE HYDROCHLORIDE AK Use of Metvixia with a new Lamp (Aktilite) in AKs Other Phototoxic Phototoxic Agent Cytotoxic Agent 59
2008-10-15 DENILEUKIN DIFTITOX CTCL Regular Approval for Persistent or Recurrent CD25+ Cutaneous T-Cell Lymphoma Other Cytokine-Cytotoxin Cytokine-Cytotoxin Cytotoxic Agent 60
2009-11-05 ROMIDEPSIN CTCL Refractory Cutaneous T-Cell Lymphoma Refractory HDAC Inhibitor HDAC Inhibitor HDAC Inhibitor 61
2010-03-12 AMINOLEVULINIC ACID HYDROCHLORIDE AK Allow user to mix contents for 30 seconds prior to use & to use 'Kerastick Krusher' Other Phototoxic Phototoxic Agent Cytotoxic Agent 62
2010-03-25 IMIQUIMOD AK Use of 3.75% form for Actinic Keratoses of the Full Face or Balding Scalp Other TLR Agonist TLR Agonist Immunotherapy 63
2011-03-25 IPILIMUMAB Melanoma Unresectable or Metastatic Melanoma Locally Advanced or Metastatic CTLA-4 Ab CTLA-4 Targeted Antibody Immunotherapy 64
2011-03-29 PEGINTERFERON ALFA-2B Melanoma Adjuvant Melanoma Adjuvant Cytokine Cytokine Immunotherapy 65
2011-07-15 IMIQUIMOD AK Use of 2.5% cream for AKs on face and scalp Other TLR Agonist TLR Agonist Immunotherapy 66
2011-08-17 VEMURAFENIB Melanoma Unresectable or Metastatic Melanoma Locally Advanced or Metastatic Kinase Inhibitor Kinase Inhibitor Targeted Therapy 67
2012-01-23 INGENOL MEBUTATE AK Actinic Keratoses Other Cytotoxic Agent Cytotoxic Agent Cytotoxic Agent 68
2012-01-30 VISMODEGIB BCC Locally Advanced or Metastatic Basal Cell Carcinoma Locally Advanced or Metastatic Smoothened Inhibitor Smoothened Inhibitor Targeted Therapy 69
2013-05-29 TRAMETINIB DIMETHYL SULFOXIDE Melanoma Unresectable or Metastatic BRAF-Mutated Melanoma Locally Advanced or Metastatic Kinase Inhibitor Kinase Inhibitor Targeted Therapy 70
2013-05-29 DABRAFENIB MESYLATE Melanoma Single agent, first-line in advanced BRAF-mutated melanoma Locally Advanced or Metastatic Kinase Inhibitor Kinase Inhibitor Targeted Therapy 71
2013-08-23 MECHLORETHAMINE HYDROCHLORIDE CTCL Refractory Stage IA and IB Cutaneous T-Cell Lymphoma Refractory Alkylating Agent Alkylating Agent Cytotoxic Agent 72
2014-01-08 TRAMETINIB DIMETHYL SULFOXIDE Melanoma Unresectable or Metastatic BRAF-Mutated Melanoma Locally Advanced or Metastatic Kinase Inhibitor Kinase Inhibitor Targeted Therapy 73
2014-01-09 DABRAFENIB MESYLATE Melanoma Accelerated approval for Dab/Tram in advanced BRAF mutant melanoma Locally Advanced or Metastatic Kinase Inhibitor Kinase Inhibitor Targeted Therapy 74
2014-09-04 PEMBROLIZUMAB Melanoma Unresectable or Metastatic Melanoma - Second Line Refractory PD-1 Ab PD-1 Targeted Antibody Immunotherapy 75
2014-12-22 NIVOLUMAB Melanoma Accelerated Approval for Unresectable or Metastatic Melanoma in the Second-Line Setting Locally Advanced or Metastatic PD-1 Ab PD-1 Targeted Antibody Immunotherapy 76
2015-07-24 SONIDEGIB PHOSPHATE BCC Locally Advanced Basal Cell Carcinoma Locally Advanced Smoothened Inhibitor Smoothened Inhibitor Targeted Therapy 77
2015-09-30 NIVOLUMAB Melanoma Accelerated Approval of OPDIVO with YERVOY in BRAF Wild Type Unresectable or Metastatic Melanoma Locally Advanced or Metastatic PD-1 Ab PD-1 Targeted Antibody Immunotherapy 78
2015-10-27 TALIMOGENE LAHERPAREPVEC Melanoma Unresectable Cutaneous, Subcutaneous, and Nodal Recurrent Melanoma Locally Advanced Oncolytic Virus Oncolytic Virus Immunotherapy 79
2015-10-28 IPILIMUMAB Melanoma Adjuvant Melanoma Adjuvant CTLA-4 Ab CTLA-4 Targeted Antibody Immunotherapy 80
2015-11-10 COBIMETINIB FUMARATE Melanoma Unresectable or Metastatic Melanoma with a BRAF-Mutated Melanoma In Combination with Vemurafenib Locally Advanced or Metastatic Kinase Inhibitor Kinase Inhibitor Targeted Therapy 81
2015-11-19 INGENOL MEBUTATE AK Describing response to a repeat course Other Cytotoxic Agent Cytotoxic Agent Cytotoxic Agent 82
2015-11-20 TRAMETINIB DIMETHYL SULFOXIDE Melanoma Unresectable or Metastatic Melanoma with a BRAF-Mutated Melanoma In Combination with Dabrafenib Locally Advanced or Metastatic Kinase Inhibitor Kinase Inhibitor Targeted Therapy 83
2015-11-20 DABRAFENIB MESYLATE Melanoma Regular approval for Dab/Tram in advanced BRAF mutant melanoma Locally Advanced or Metastatic Kinase Inhibitor Kinase Inhibitor Targeted Therapy 84
2015-11-23 NIVOLUMAB Melanoma Regular Approval for Unresectable or Metastatic BRAF-Wild Type Melanoma Locally Advanced or Metastatic PD-1 Ab PD-1 Targeted Antibody Immunotherapy 85
2015-12-18 PEMBROLIZUMAB Melanoma Unresectable or Metastatic Melanoma Locally Advanced or Metastatic PD-1 Ab PD-1 Targeted Antibody Immunotherapy 86
2015-12-18 PEMBROLIZUMAB Melanoma Removing language limiting the indication to disease progression following ipilimumab Other PD-1 Ab PD-1 Targeted Antibody Immunotherapy 87
2016-01-23 NIVOLUMAB Melanoma Accelerated Approved for BRAF Mutant Unresectable or Metastatic Melanoma in the First Line Setting Locally Advanced or Metastatic PD-1 Ab PD-1 Targeted Antibody Immunotherapy 88
2016-01-23 NIVOLUMAB Melanoma Accelerated approval of Ipi/Nivo Expansion for BRAF mutant as well as BRAF WT Other PD-1 Ab PD-1 Targeted Antibody Immunotherapy 89
2016-05-10 AMINOLEVULINIC ACID HYDROCHLORIDE AK Actinic keratoses of mild-to-moderate severity on the face and scalp Other Phototoxic Phototoxic Agent Cytotoxic Agent 90
2016-09-13 NIVOLUMAB Melanoma Flat Dosing for Melanoma, NSCLC and RCC Dosing Adjustment PD-1 Ab PD-1 Targeted Antibody Immunotherapy 91
2016-09-13 NIVOLUMAB Melanoma Flat Dosing for Melanoma, NSCLC and RCC Dosing Adjustment PD-1 Ab PD-1 Targeted Antibody Immunotherapy 92
2017-03-23 AVELUMAB MCC Metastatic Merkel Cell Carcinoma Metastatic PD-L1 Ab PD-L1 Targeted Antibody Immunotherapy 93
2017-05-17 PEMBROLIZUMAB Melanoma Flat Dosing of 200 mg q3 weeks in melanoma Dosing Adjustment PD-1 Ab PD-1 Targeted Antibody Immunotherapy 94
2017-05-23 PEMBROLIZUMAB Agnostic Unresectable or Metastatic, Microsatellite Instability-High or Mismatch Repair Deficient Solid Tumors Locally Advanced or Metastatic PD-1 Ab PD-1 Targeted Antibody Immunotherapy 95
2017-07-21 IPILIMUMAB Melanoma Unresectable or Metastatic Melanoma - patients 12 years and older Locally Advanced or Metastatic CTLA-4 Ab CTLA-4 Targeted Antibody Immunotherapy 96
2017-11-09 BRENTUXIMAB VEDOTIN CTCL CD30+ MF and pcALCL in the second line Refractory CD30 Ab CD30 Targeted Antibody Targeted Therapy 97
2017-12-20 NIVOLUMAB Melanoma Regular Approval for Adjuvant Melanoma Adjuvant PD-1 Ab PD-1 Targeted Antibody Immunotherapy 98
2018-01-09 NIVOLUMAB Melanoma Updates infusion from 60 to 30 minutes Other PD-1 Ab PD-1 Targeted Antibody Immunotherapy 99
2018-01-26 COBIMETINIB FUMARATE Melanoma Updates label to include OS data Other Kinase Inhibitor Kinase Inhibitor Targeted Therapy 100
2018-03-05 NIVOLUMAB Melanoma Every 4 Week Dosing for Advanced Melanoma Dosing Adjustment PD-1 Ab PD-1 Targeted Antibody Immunotherapy 101
2018-03-05 NIVOLUMAB Melanoma Every 4 week dosing in Adjuvant Melanoma Adjuvant PD-1 Ab PD-1 Targeted Antibody Immunotherapy 102
2018-03-05 NIVOLUMAB Melanoma Updates infusion from 60 to 30 minutes in adjuvant Melanoma Adjuvant PD-1 Ab PD-1 Targeted Antibody Immunotherapy 103
2018-03-06 AMINOLEVULINIC ACID HYDROCHLORIDE AK Minimally to moderately thick Actinic Keratosis of the upper extremities Other Phototoxic Phototoxic Agent Cytotoxic Agent 104
2018-04-30 TRAMETINIB DIMETHYL SULFOXIDE Melanoma Adjuvant BRAF Mutant Melanoma In Combination with Dabrafenib Adjuvant Kinase Inhibitor Kinase Inhibitor Targeted Therapy 105
2018-04-30 DABRAFENIB MESYLATE Melanoma Adjuvant BRAF Mutant Melanoma In Combination with Trametinib Adjuvant Kinase Inhibitor Kinase Inhibitor Targeted Therapy 106
2018-06-27 ENCORAFENIB Melanoma Regular Approval for use in combination with binimetinib for advanced BRAF mutant melanoma Locally Advanced or Metastatic Kinase Inhibitor Kinase Inhibitor Targeted Therapy 107
2018-06-27 BINIMETINIB Melanoma Unresectable or Metastatic BRAF-Mutated Melanoma In Combination with Encorafenib Locally Advanced or Metastatic Kinase Inhibitor Kinase Inhibitor Targeted Therapy 108
2018-08-08 MOGAMULIZUMAB-KPKC CTCL Relapsed/Refractory Mycosis Fungoides or Sezary Syndrome - Second Line Refractory CCR4 Ab CCR4 Targeted Antibody & ADCC Inducer Immunotherapy 109
2018-09-28 CEMIPLIMAB-RWLC SCC Locally Advanced or Metastatic Squamous Cell Carcinoma Locally Advanced or Metastatic PD-1 Ab PD-1 Targeted Antibody Immunotherapy 110
2018-12-19 PEMBROLIZUMAB MCC Locally Advanced or Metastatic Merkel Cell Carcinoma Locally Advanced or Metastatic PD-1 Ab PD-1 Targeted Antibody Immunotherapy 111
2019-01-18 VISMODEGIB BCC To allow for treatment interruptions of up to 8 weeks for intolerable AEs Other Smoothened Inhibitor Smoothened Inhibitor Targeted Therapy 112
2019-02-15 PEMBROLIZUMAB Melanoma Adjuvant Melanoma Adjuvant PD-1 Ab PD-1 Targeted Antibody Immunotherapy 113
2019-03-07 NIVOLUMAB Melanoma Conversion to Regular Approval for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma Locally Advanced or Metastatic PD-1 Ab PD-1 Targeted Antibody Immunotherapy 114
2019-03-07 NIVOLUMAB Melanoma Conversion to Regular Approval of OPDIVO, in combination with ipilimumab, for the treatment of patients with unresectable or metastatic melanoma Locally Advanced or Metastatic PD-1 Ab PD-1 Targeted Antibody Immunotherapy 115
2019-10-06 TRAMETINIB DIMETHYL SULFOXIDE Melanoma Updating results in subjects with brain metastases Other Kinase Inhibitor Kinase Inhibitor Targeted Therapy 116
2019-10-06 DABRAFENIB MESYLATE Melanoma Updates label in regards to brain mets for melanoma Other Kinase Inhibitor Kinase Inhibitor Targeted Therapy 117
2020-04-28 PEMBROLIZUMAB Melanoma Every 6 weeks dosing in Melanoma Dosing Adjustment PD-1 Ab PD-1 Targeted Antibody Immunotherapy 118
2020-04-28 PEMBROLIZUMAB MCC Every 6 weeks dosing in Merkel Cell Carcinoma Dosing Adjustment PD-1 Ab PD-1 Targeted Antibody Immunotherapy 119
2020-04-28 PEMBROLIZUMAB Agnostic Every 6 weeks dosing in MSI-H tumors Dosing Adjustment PD-1 Ab PD-1 Targeted Antibody Immunotherapy 120
2020-05-14 POMALIDOMIDE KS Treatment of adult patients with AIDS-related Kaposi sarcoma Other Immunomodulatory Cereblon Inhibitor Imid 121
2020-05-14 POMALIDOMIDE KS Treatment of Kaposi’s Sarcoma in patients who are HIV-negative Other Immunomodulatory Cereblon Inhibitor Imid 122
2020-06-16 PEMBROLIZUMAB Agnostic Tumor Mutation Burden-High solid tumors Other PD-1 Ab PD-1 Targeted Antibody Immunotherapy 123
2020-06-16 PEMBROLIZUMAB Agnostic Every 6 weeks dosing in TMB-H tumors Dosing Adjustment PD-1 Ab PD-1 Targeted Antibody Immunotherapy 124
2020-06-24 PEMBROLIZUMAB SCC r/mCSCC Locally Advanced or Metastatic PD-1 Ab PD-1 Targeted Antibody Immunotherapy 125
2020-06-24 PEMBROLIZUMAB SCC Every 6 weeks dosing for CSCC Dosing Adjustment PD-1 Ab PD-1 Targeted Antibody Immunotherapy 126
2020-07-30 ATEZOLIZUMAB Melanoma Unresectable or metastatic BRAF-mutated melanoma in combination with cobimetinib and vemurafenib Locally Advanced or Metastatic PD-L1 Ab PD-L1 Targeted Antibody Immunotherapy 127
2020-12-14 TIRBANIBULIN AK Actinic keratosis of the face or scalp Other Microtubule Inhibitor Microtubule Inhibitor Cytotoxic Agent 128
2021-02-09 CEMIPLIMAB-RWLC BCC Locally Advanced Basal Cell Carcinoma Locally Advanced PD-1 Ab PD-1 Targeted Antibody Immunotherapy 129
2021-02-09 CEMIPLIMAB-RWLC BCC Metastatic Basal Cell Carcinoma Metastatic PD-1 Ab PD-1 Targeted Antibody Immunotherapy 130
2021-07-01 PEMBROLIZUMAB SCC laCSCC Locally Advanced PD-1 Ab PD-1 Targeted Antibody Immunotherapy 131
2021-12-03 PEMBROLIZUMAB Melanoma Adjuvant Stage IIB and IIC Melanoma Adjuvant PD-1 Ab PD-1 Targeted Antibody Immunotherapy 132
2022-01-25 TEBENTAFUSP-TEBN Melanoma HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma Locally Advanced or Metastatic Bispecific Antibody Bispecific gp100 peptide-HLA-A*02:01 directed T cell receptor CD3 T cell engager Immunotherapy 133
2022-03-18 RELATLIMAB-RMBW Melanoma Unresectable or Metastatic Melanoma Locally Advanced or Metastatic LAG-3 Ab LAG-3 Targeted Antibody Immunotherapy 134

fda_approval_timeseries_plot( )

When used in isolation

fda_approval_timeseries_plot(
    .legendorientationy = 1.1
)

When used in conjuction with fda_approvals_timeseries_df()

skincancerRx_data |> 
  filter(Dz == "Melanoma") |> 
  fda_approval_timeseries_df() |> 
  fda_approval_timeseries_plot(
    .title = "<b>FDA Approvals in Melanoma<b>",
    .legend= FALSE,
    .startdate = "1966-01-01",
    .hoverlabeltextsize = 12
)

response_rate_df( )

response_rate_df() |> 
    kable() %>%
    kable_styling(bootstrap_options = c("striped","hover"),
                  fixed_thead = T) %>%
    scroll_box(height = "400px",
               width = "100%")
name application_number Indication Indication_brief submission_class_code_description Action_Date Dz Endpoint_shortened Effect_Estimate N Response_Rate lb_95CI ub_95CI lb_95CI_proposed Toolshort Mechanism_long Action_Date_jitter Drug Name (Indication)
Interferon Alfa-2a BLA103145 Roferon-A is indicated for the treatment of chronic hepatitis C, hairy cell leukemia and AIDS-related Kaposi's sarcoma in patients 18 years of age or older. In addition, it is indicated for chronic phase, Philadelphia chromosome (Ph) positive chronic myelogenous leukemia (CML) patients who are minimally pretreated (within 1 year of diagnosis). AIDS KS Efficacy 1988-11-21 KS Response Rate NA 350 25.5 15.1 27.9 NA NA Cytokine 1988-08-21 Interferon Alfa-2a (AIDS KS)
Interferon Alfa-2b BLA103132 INTRON A is indicated for the treatment of selected patients 18 years of age or older with AIDS-Related Kaposi's Sarcoma AIDS KS Efficacy 1988-11-21 KS Response Rate NA 72 29.2 19.0 41.1 NA NA Cytokine 1988-11-21 Interferon Alfa-2b (AIDS KS)
Interferon Alfa-2b BLA103132 INTRON A is indicated for the treatment of selected patients 18 years of age or older with AIDS-Related Kaposi's Sarcoma AIDS KS Efficacy 1988-11-21 KS Response Rate NA 23 30.4 13.2 52.9 NA NA Cytokine 1989-02-21 Interferon Alfa-2b (AIDS KS)
Doxorubicin NDA050718 The treatment of AIDS-related Kaposi’s sarcoma in patients after failure or prior systemic chemotherapy or intolerance to such therapy. has progressed on prior combination chemotherapy or in patients who are intolerant to such therapy AIDS KS (AA) Type 3 - New Dosage Form 1995-11-17 KS Response Rate NA 34 27.0 12.9 44.4 NA ACTG Topoisomerase Inhibitor 1995-11-17 Doxorubicin (AIDS KS (AA))
Doxorubicin NDA050718 The treatment of AIDS-related Kaposi’s sarcoma in patients after failure or prior systemic chemotherapy or intolerance to such therapy. has progressed on prior combination chemotherapy or in patients who are intolerant to such therapy AIDS KS (AA) Type 3 - New Dosage Form 1995-11-17 KS Response Rate NA 42 48.0 32.0 63.6 NA ACTG Topoisomerase Inhibitor 1996-02-17 Doxorubicin (AIDS KS (AA))
Paclitaxel NULL Second-line therapy in patients with AIDS-related Kaposi's sarcoma AIDS KS Efficacy 1997-08-04 KS Response Rate NA 59 59.0 45.7 71.9 NA ACTG Microtubule Stabilizer 1997-08-04 Paclitaxel (AIDS KS)
Aldesleukin BLA103293 Proleukin is indicated for the treatment of adults with metastatic melanoma mMelanoma Efficacy 1998-01-09 Melanoma Objective Response Rate NA 270 15.9 11.8 20.8 NA 2D Measurement Cytokine 1998-01-09 Aldesleukin (mMelanoma)
Methoxsalen NDA020969 UVADEX® (methoxsalen) Sterile Solution is indicated for extracorporeal administration with the THERAKOS® UVAR XTS® or THERAKOS® CELLEX® Photopheresis System in the palliative treatment of the skin manifestations of Cutaneous T-Cell Lymphoma (CTCL) that is unresponsive to other forms of treatment rCTCL Type 3 - New Dosage Form 1999-02-25 CTCL Response Rate 12 51 33.3 20.8 47.9 25 Composite Phototoxic Agent 1999-02-25 Methoxsalen (rCTCL)
Bexarotene NDA021055 Targretin® (bexarotene) capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. rCTCL Type 1 - New Molecular Entity 1999-12-29 CTCL Response Rate 27 62 32.2 20.9 45.3 5 Composite Retinoid 1999-12-29 Bexarotene (rCTCL)
Bexarotene Gel NDA021056 Targretin® (bexarotene) gel 1% is indicated for the topical treatment of cutaneous lesions in patients with CTCL (Stage IA and IB) who have refractory or persistent disease after other therapies or who have not tolerated other therapies. rCTCL Type 3 - New Dosage Form 2000-06-28 CTCL Response Rate 21 50 26.0 14.6 40.3 5 Composite Retinoid 2000-06-28 Bexarotene Gel (rCTCL)
Vorinostat NDA021991 ZOLINZA is a histone deacetylase (HDAC) inhibitor indicated for: Treatment of cutaneous manifestations in patients with cutaneous Tcell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies rCTCL Type 1 - New Molecular Entity 2006-10-06 CTCL Response Rate 24.7 74 29.7 19.7 41.5 5 mSWAT HDAC Inhibitor 2006-07-06 Vorinostat (rCTCL)
Vorinostat NDA021991 ZOLINZA is a histone deacetylase (HDAC) inhibitor indicated for: Treatment of cutaneous manifestations in patients with cutaneous Tcell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies rCTCL Type 1 - New Molecular Entity 2006-10-06 CTCL Response Rate 24.7 33 24.2 11.1 42.3 5 mSWAT HDAC Inhibitor 2006-10-06 Vorinostat (rCTCL)
Imatinib NDA021588 GLEEVEC is indicated for adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP) u/mDFSP Efficacy 2006-10-19 DFSP Overall Response Rate NA 18 83.3 58.6 96.4 NA NA Kinase Inhibitor 2007-02-01 Imatinib (u/mDFSP)
Doxorubicin NDA050718 DOXIL is an anthracycline topoisomerase inhibitor indicated for AIDS-related Kaposi’s Sarcoma after failure of prior systemic chemotherapy or intolerance to such therapy AIDS KS Efficacy 2008-06-10 KS Overall Response Rate NA 17 41.2 18.4 67.1 NA NA Topoisomerase Inhibitor 2008-06-10 Doxorubicin (AIDS KS)
Doxorubicin NDA050718 DOXIL is an anthracycline topoisomerase inhibitor indicated for AIDS-related Kaposi’s Sarcoma after failure of prior systemic chemotherapy or intolerance to such therapy AIDS KS Efficacy 2008-06-10 KS Overall Response Rate NA 11 36.4 10.9 69.2 NA NA Topoisomerase Inhibitor 2008-09-10 Doxorubicin (AIDS KS)
Romidepsin NDA022393 ISTODAX is a histone deacetylase (HDAC) inhibitor indicated for: Treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy rCTCL Type 1 - New Molecular Entity 2009-11-05 CTCL Objective Response Rate 19 96 34.0 25.0 45.0 15 Composite HDAC Inhibitor 2009-08-05 Romidepsin (rCTCL)
Romidepsin NDA022393 ISTODAX is a histone deacetylase (HDAC) inhibitor indicated for: Treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy rCTCL Type 1 - New Molecular Entity 2009-11-05 CTCL Objective Response Rate 19 71 35.0 25.0 49.0 15 Composite HDAC Inhibitor 2009-11-05 Romidepsin (rCTCL)
Vismodegib NDA203388 ERIVEDGE™ (vismodegib) capsule is a hedgehog pathway inhibitor indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation mBCC Type 1 - New Molecular Entity 2012-01-30 BCC Objective Response Rate 20.3 | 22.9 33 30.3 15.6 48.2 10 mRECIST Smoothened Inhibitor 2012-04-30 Vismodegib (mBCC)
Vismodegib NDA203388 ERIVEDGE™ (vismodegib) capsule is a hedgehog pathway inhibitor indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation laBCC Type 1 - New Molecular Entity 2012-01-30 BCC Objective Response Rate 20.3 | 22.9 63 42.9 30.5 56.0 20 mRECIST Smoothened Inhibitor 2012-01-30 Vismodegib (laBCC)
Pembrolizumab BLA125514 KEYTRUDA is a human programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. u/mMelanoma Type 1 - New Molecular Entity 2014-09-04 Melanoma Overall Response Rate 13.6 173 23.6 15.0 34.0 10 mRECIST PD-1 Targeted Antibody 2014-09-04 Pembrolizumab (u/mMelanoma)
Nivolumab BLA125554 OPDIVO is a human programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. u/mMelanoma Type 1 - New Molecular Entity 2014-12-22 Melanoma Overall Response Rate 17 120 32.0 23.0 41.0 15 RECIST PD-1 Targeted Antibody 2014-12-22 Nivolumab (u/mMelanoma)
Sonidegib NDA205266 ODOMZO is a hedgehog pathway inhibitor indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. laBCC Type 1 - New Molecular Entity 2015-07-24 BCC Objective Response Rate 38 66 57.5 44.7 69.7 20 mRECIST Smoothened Inhibitor 2015-07-24 Sonidegib (laBCC)
Avelumab BLA761049 BAVENCIO is a programmed death ligand-1 (PD-L1) blocking antibody indicated for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC) mMCC Type 1 - New Molecular Entity 2017-03-23 MCC Overall Response Rate 13 88 33.0 23.3 43.8 20 RECIST PD-L1 Targeted Antibody 2017-03-23 Avelumab (mMCC)
Pembrolizumab BLA125514 U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co.) for adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options or with MSI-H or dMMR colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. MSI-hi Efficacy 2017-05-23 Agnostic Objective Response Rate & Duration of Response NA 149 39.6 31.7 47.9 NA mRECIST PD-1 Targeted Antibody 2017-05-23 Pembrolizumab (MSI-hi)
Cemiplimab-rwlc BLA761097 LIBTAYO is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation mCSCC Type 1 - New Molecular Entity 2018-09-28 SCC Overall Response Rate 31.7 | 23.5 75 46.7 35.1 58.6 15 Composite PD-1 Targeted Antibody 2018-06-28 Cemiplimab-rwlc (mCSCC)
Cemiplimab-rwlc BLA761097 LIBTAYO is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation laCSCC Type 1 - New Molecular Entity 2018-09-28 SCC Overall Response Rate 31.7 | 23.5 33 48.5 30.8 66.5 25 Composite PD-1 Targeted Antibody 2018-09-28 Cemiplimab-rwlc (laCSCC)
Pembrolizumab BLA125514 For the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma la/mMCC Efficacy 2018-12-19 MCC Overall Response Rate & Duration of Response NA 50 56.0 41.0 70.0 NA RECIST PD-1 Targeted Antibody 2018-12-19 Pembrolizumab (la/mMCC)
Trametinib NDA204114 Updating results in subjects with BRAF mutation-positive melanoma that has metastasized to the brain mMelanoma Efficacy 2019-10-06 Melanoma Overall Response Rate NA 121 50.0 40.0 60.0 NA mRECIST Kinase Inhibitor 2019-07-06 Trametinib (mMelanoma)
Dabrafenib NDA202806 Updates to the CLINICAL STUDIES (14.2) section in the TAFINLAR United States Prescribing Information (USPI) adding the results of Study BRF117277 (Novartis study code CDRB436B2204; “the COMBI-MB study”), a non-randomized, open-label, multi-center, multi-cohort trial of dabrafenib plus trametinib in subjects with BRAF mutation-positive melanoma that has metastasized to the brain mMelanoma Efficacy 2019-10-06 Melanoma Overall Response Rate NA 121 50.0 40.0 60.0 NA mRECIST Kinase Inhibitor 2019-10-06 Dabrafenib (mMelanoma)
Pomalidomide NDA204026 New indication for the treatment of adult patients with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) HIV-pos KS Efficacy 2020-05-14 KS Objective Response Rate NA 18 67.0 41.0 86.6 NA ACTG Cereblon Inhibitor 2020-05-01 Pomalidomide (HIV-pos KS)
Pomalidomide NDA204026 Treatment of Kaposi’s Sarcoma in patients who are HIV-negative HIV-neg KS Efficacy 2020-05-14 KS Objective Response Rate NA 10 80.0 44.4 97.5 NA ACTG Cereblon Inhibitor 2020-05-14 Pomalidomide (HIV-neg KS)
Pembrolizumab BLA125514 This supplement modifies the previous label for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options TMB-hi Efficacy 2020-06-16 Agnostic Objective Response Rate & Duration of Response NA 102 29.0 21.0 39.0 NA mRECIST PD-1 Targeted Antibody 2020-06-16 Pembrolizumab (TMB-hi)
Pembrolizumab BLA125514 This Prior Approval supplemental biologics application adds a new indication for KEYTRUDA, for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation r/mCSCC Efficacy 2020-06-24 SCC Objective Response Rate 34.299999999999997 105 34.3 25.2 44.2 15 mRECIST PD-1 Targeted Antibody 2020-08-24 Pembrolizumab (r/mCSCC)
Cemiplimab-rwlc BLA761097 For the treatment of patients with locally advanced BCC (laBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate laBCC Efficacy 2021-02-09 BCC Objective Response Rate NA 112 29.0 19.0 40.0 20 Composite PD-1 Targeted Antibody 2020-11-09 Cemiplimab-rwlc (laBCC)
Cemiplimab-rwlc BLA761097 For the treatment of patients with metastatic BCC (mBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate mBCC Efficacy 2021-02-09 BCC Objective Response Rate NA 112 21.0 8.0 41.0 NA Composite PD-1 Targeted Antibody 2021-02-09 Cemiplimab-rwlc (mBCC)
Pembrolizumab BLA125514 A new indication for pembrolizumab for locally advanced cSCC that is not curable by surgery or radiation laCSCC Efficacy 2021-07-01 SCC Objective Response Rate NA 54 50.0 36.0 64.0 NA mRECIST PD-1 Targeted Antibody 2021-07-01 Pembrolizumab (laCSCC)

response_rate_plot( )

response_rate_plot(
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  .pointpositionY = 105,
  .pointsize = 3,
  .xlabelpositionX = "1988-01-01",
  .xlabelpositionY = 98,
  .xsize = 4,
  .responsepositionX = "2002-01-01",
  .responsepositionY = 105,
  .lowerboundtextpositionX = "2001-09-01",
  .lowerboundtextpositionY = 98
)

Getting help

If you encounter a clear bug, please file an issue with a minimal reproducible example on GitHub.

Disclaimer and Acknowledgements

skincancerRx is for research purposes only. No clinical decisions should be made with the information obtained from its output.