Table 1. Therapies with Indications for Skin Cancer



Therapeutic(s) BLA/NDA Indication Submission Class Action Date Skin Neoplasia Primary Endpoint Subjects Enrolled Lower Bound 95% CI (%) Assessment Tool Accelerated Approval Mechanism
MECHLORETHAMINE HYDROCHLORIDE NDA006695 Mycosis Fungoides Type 1 - New Molecular Entity 1949-03-15 CTCL NA NA NA NA No Alkylating Agent
CORTISONE ACETATE NDA007110 Mycosis Fungoides Type 1 - New Molecular Entity 1950-06-13 CTCL NA NA NA NA No Glucocorticoid
CORTISONE ACETATE NDA007750 Mycosis Fungoides Type 3 - New Dosage Form 1950-12-04 CTCL NA NA NA NA No Glucocorticoid
HYDROCORTISONE NDA008697 Mycosis Fungoides Type 5 - New Formulation or New Manufacturer 1952-12-15 CTCL NA NA NA NA No Glucocorticoid
METHOTREXATE SODIUM NULL Mycosis Fungoides Type 1 - New Molecular Entity 1953-12-07 CTCL Response Rate NA NA NA No Antimetabolite
PREDNISONE NDA009766 Mycosis Fungoides Type 1 - New Molecular Entity 1955-02-21 CTCL NA NA NA NA No Glucocorticoid
HYDROCORTISONE SODIUM SUCCINATE NDA009866 Mycosis Fungoides Type 2 - New Active Ingredient 1955-04-27 CTCL NA NA NA NA No Glucocorticoid
PREDNISOLONE NDA009987 Mycosis Fungoides Type 1 - New Molecular Entity 1955-06-21 CTCL NA NA NA NA No Glucocorticoid
METHYLPREDNISOLONE NDA011153 Mycosis Fungoides Type 1 - New Molecular Entity 1957-10-24 CTCL NA NA NA NA No Glucocorticoid
TRIAMCINOLONE NDA011161 Mycosis Fungoides Type 1 - New Molecular Entity 1957-12-03 CTCL NA NA NA NA No Glucocorticoid
DEXAMETHASONE NDA011664 Mycosis Fungoides Type 1 - New Molecular Entity 1958-10-30 CTCL NA NA NA NA No Glucocorticoid
TRIAMCINOLONE DIACETATE NDA011685 Mycosis Fungoides Type 2 - New Active Ingredient 1959-03-12 CTCL NA NA NA NA No Glucocorticoid
METHYLPREDNISOLONE SODIUM SUCCINATE NDA011856 Mycosis Fungoides Type 2 - New Active Ingredient 1959-05-18 CTCL NA NA NA NA No Glucocorticoid
METHYLPREDNISOLONE ACETATE NDA011757 Mycosis Fungoides Type 2 - New Active Ingredient 1959-05-27 CTCL NA NA NA NA No Glucocorticoid
METHOTREXATE SODIUM NDA011719 Mycosis Fungoides Type 2 - New Active Ingredient 1959-08-10 CTCL Response Rate NA NA NA No Antimetabolite
DEXAMETHASONE SODIUM PHOSPHATE NDA012071 Mycosis Fungoides Type 3 - New Dosage Form 1959-10-06 CTCL NA NA NA NA No Glucocorticoid
CYCLOPHOSPHAMIDE NDA012142 Mycosis Fungoides Type 2 - New Active Ingredient 1959-11-16 CTCL NA NA NA NA No Alkylating Agent
CYCLOPHOSPHAMIDE NDA012141 Mycosis Fungoides Type 1 - New Molecular Entity 1959-11-16 CTCL NA NA NA NA No Alkylating Agent
METHYLPREDNISOLONE ACETATE NDA012421 Mycosis Fungoides Type 3 - New Dosage Form 1960-06-21 CTCL NA NA NA NA No Glucocorticoid
DEXAMETHASONE NDA012376 Mycosis Fungoides Type 3 - New Dosage Form 1960-07-07 CTCL NA NA NA NA No Glucocorticoid
BETAMETHASONE NDA012657 Mycosis Fungoides Type 1 - New Molecular Entity 1961-04-17 CTCL NA NA NA NA No Glucocorticoid
TRIAMCINOLONE DIACETATE NDA012802 Mycosis Fungoides Type 5 - New Formulation or New Manufacturer 1961-09-05 CTCL NA NA NA NA No Glucocorticoid
TRIAMCINOLONE ACETONIDE NDA014901 Mycosis Fungoides Type 5 - New Formulation or New Manufacturer 1965-02-01 CTCL NA NA NA NA No Glucocorticoid
BETAMETHASONE ACETATE NDA014602 Mycosis Fungoides Type 1 - New Molecular Entity 1965-03-03 CTCL NA NA NA NA No Glucocorticoid
VINBLASTINE SULFATE NDA012665 Mycosis Fungoides Type 1 - New Molecular Entity 1965-11-25 CTCL NA NA NA NA No Microtubule Inhibitor
VINBLASTINE SULFATE NDA012665 Kaposi’s Sarcoma Type 1 - New Molecular Entity 1965-11-25 KS NA NA NA NA No Microtubule Inhibitor
HYDROXYUREA NDA016295 Melanoma Type 1 - New Molecular Entity 1967-12-07 Melanoma Overall Response Rate NA NA NA No Anti-Metabolite
FLUOROURACIL NDA016831 Multiple Actinic Keratoses Type 3 - New Dosage Form 1970-07-29 AK NA NA NA NA NA Anti-Metabolite
FLUOROURACIL NDA016988 Actinic Keratoses Type 5 - New Formulation or New Manufacturer 1971-08-06 AK NA NA NA NA No Anti-Metabolite
DACARBAZINE NDA017575 Metastatic Malignant Melanoma Type 1 - New Molecular Entity 1975-05-27 Melanoma Overall Response Rate 580 NA NA No Alkylating Agent
FLUOROURACIL NDA016831 Superficial Basal Cell Carcinoma Efficacy 1975-06-30 BCC Complete Clearance Rate 54 NA NA No Anti-Metabolite
PREDNISOLONE SODIUM PHOSPHATE NDA019157 Mycosis Fungoides Type 3 - New Dosage Form 1986-05-28 CTCL Bioequivalence 12 NA PK No Glucocorticoid
METHOXSALEN NDA009048 Refractory Cutaneous T-Cell Lymphoma Efficacy 1988-03-23 CTCL Response Rate 39 NA NA No Phototoxic Agent
INTERFERON ALFA-2B BLA103132 AIDS-Related Kaposi’s Sarcoma Efficacy 1988-11-21 KS Response Rate 144 NA NA No Cytokine
INTERFERON ALFA-2A BLA103145 AIDS-Related Kaposi’s Sarcoma Efficacy 1988-11-21 KS Response Rate 350 NA NA No Cytokine
DOXORUBICIN HYDROCHLORIDE NDA050718 Accelerated Approval for Refractory AIDS-Related Kaposi’s Sarcoma Type 3 - New Dosage Form 1995-11-17 KS Response Rate 77 NA ACTG Yes Topoisomerase Inhibitor
INTERFERON ALFA-2B BLA103132 Adjuvant Melanoma Efficacy 1995-12-05 Melanoma Relapse-Free Survival 280 NA Clinical No Cytokine
DAUNORUBICIN CITRATE NDA050704 HIV-associated Kaposi’s Sarcoma - First Line Type 3 - New Dosage Form 1996-04-08 KS Response Rate 227 NA ACTG No Topoisomerase Inhibitor
PACLITAXEL NDA020262 AIDS-Related Kaposi’s Sarcoma - Second Line Efficacy 1997-08-04 KS Response Rate 59 NA ACTG No Microtubule Stabilizer
ALDESLEUKIN BLA103293 Metastatic Melanoma Efficacy 1998-01-09 Melanoma Overall Response Rate 270 NA 2D Measurement No Cytokine
PREDNISOLONE SODIUM PHOSPHATE NDA019157 Expansion to include pediatric populations Efficacy 1998-12-17 CTCL NA NA NA NA No Glucocorticoid
ALITRETINOIN NDA020886 AIDS-Related Kaposi’s Sarcoma - Cutaneous Lesions Only Type 1 - New Molecular Entity 1999-02-02 KS Response Rate 350 NA ACTG No Retinoid
DENILEUKIN DIFTITOX BLA103767 Accelerated Approval for Persistent or Recurrent CD25+ Cutaneous T-Cell Lymphoma Type 1 - New Molecular Entity 1999-02-05 CTCL Response Rate 71 NA SWAT Yes Cytokine-Cytotoxin
METHOXSALEN NDA020969 Refractory Cutaneous T-Cell Lymphoma Type 3 - New Dosage Form 1999-02-25 CTCL Response Rate 51 25 Composite No Phototoxic Agent
AMINOLEVULINIC ACID HYDROCHLORIDE NDA020965 Non-Hyperkeratotic Actinic Keratoses of the Face or Scalp Type 1 - New Molecular Entity 1999-12-03 AK Complete Response Rate 243 NA Clinical No Phototoxic Agent
BEXAROTENE NDA021055 Refractory Cutaneous T-Cell Lymphoma Type 1 - New Molecular Entity 1999-12-29 CTCL Response Rate 152 5 Composite No Retinoid
BEXAROTENE NDA021056 Refractory Stage IA and IB Cutaneous T-Cell Lymphoma Type 3 - New Dosage Form 2000-06-28 CTCL Response Rate 50 5 Composite No Retinoid
DICLOFENAC SODIUM NDA021005 Actinic Keratoses Type 3 - New Dosage Form 2000-10-16 AK Complete Clearance Rate 427 NA Clinical No NSAID
FLUOROURACIL NDA020985 Multiple Actinic Keratoses of the Face and Anterior Scalp Type 3 - New Dosage Form 2000-10-27 AK Complete Clearance Rate 384 NA Clinical No Anti-Metabolite
IMIQUIMOD NDA020723 Nonhypertrophic Actinic Keratoses on the Face or Scalp Efficacy 2004-03-02 AK Complete Clearance Rate 436 NA Clinical No TLR Agonist
IMIQUIMOD NDA020723 Superficial Basal Cell Carcinoma Efficacy 2004-07-14 BCC Complete Clearance Rate 364 NA Composite No TLR Agonist
METHYL AMINOLEVULINATE HYDROCHLORIDE NDA021415 Non-Keratotic Actinic Keratoses of the Face and Scalp Type 3 - New Dosage Form 2004-07-27 AK Complete Response Rate 191 NA Clinical No Phototoxic Agent
PREDNISOLONE SODIUM PHOSPHATE NDA021959 Mycosis Fungoides Type 3 - New Dosage Form 2006-06-01 CTCL Bioequivalence NA NA PK No Glucocorticoid
VORINOSTAT NDA021991 Refractory Cutaneous T-Cell Lymphoma Type 1 - New Molecular Entity 2006-10-06 CTCL Response Rate 107 5 mSWAT No Hedgehog Inhibitor
IMATINIB MESYLATE NDA021588 Unresectable, Recurrent and/or Metastatic Dermatofibrosarcoma Protuberans Efficacy 2006-10-19 DFSP Overall Response Rate 18 NA NA No Kinase Inhibitor
PREDNISOLONE ACETATE NDA022067 Mycosis Fungoides Type 3 - New Dosage Form 2008-01-17 CTCL Bioequivalence 72 NA NA No Glucocorticoid
DOXORUBICIN HYDROCHLORIDE NDA050718 Regular Aprroval for Refractory AIDS-Related Kaposi’s Sarcoma Efficacy 2008-06-10 KS Overall Response Rate 28 NA NA No Topoisomerase Inhibitor
TRIAMCINOLONE ACETONIDE NDA022220 Mycosis Fungoides Type 3 - New Dosage Form 2008-06-16 CTCL NA NA NA NA No Glucocorticoid
METHYL AMINOLEVULINATE HYDROCHLORIDE NDA021415 Use of Metvixia with a new Lamp (Aktilite) in AKs Efficacy 2008-06-26 AK Complete Response Rate 211 NA Clinical No Phototoxic Agent
DENILEUKIN DIFTITOX BLA103767 Regular Approval for Persistent or Recurrent CD25+ Cutaneous T-Cell Lymphoma Efficacy 2008-10-15 CTCL Response Rate 144 NA WSSI No Cytokine-Cytotoxin
ROMIDEPSIN NDA022393 Refractory Cutaneous T-Cell Lymphoma Type 1 - New Molecular Entity 2009-11-05 CTCL Overall Response Rate 167 15 Composite No HDAC Inhibitor
AMINOLEVULINIC ACID HYDROCHLORIDE NDA020965 Allow user to mix contents for 30 seconds prior to use & to use ‘Kerastick Krusher’ Efficacy 2010-03-12 AK NA NA NA NA No Phototoxic Agent
IMIQUIMOD NDA022483 Use of 3.75% form for Actinic Keratoses of the Full Face or Balding Scalp Type 5 - New Formulation or New Manufacturer 2010-03-25 AK Complete Clearance Rate 319 NA Clinical No TLR Agonist
IPILIMUMAB BLA125377 Unresectable or Metastatic Melanoma Type 1 - New Molecular Entity 2011-03-25 Melanoma Overall Survival 676 NA Clinical No CTLA-4 Targeted Antibody
PEGINTERFERON ALFA-2B NULL Adjuvant Melanoma Efficacy 2011-03-29 Melanoma Relapse-Free Survival 1256 NA Clinical No Cytokine
IMIQUIMOD NDA022483 Use of 2.5% cream for AKs on face and scalp Efficacy 2011-07-15 AK Complete Clearance Rate 160 NA Clinical No TLR Agonist
VEMURAFENIB NDA202429 Unresectable or Metastatic Melanoma Type 1 - New Molecular Entity 2011-08-17 Melanoma Overall Survival & Progression-Free Survival 675 NA RECIST No Kinase Inhibitor
INGENOL MEBUTATE NDA202833 Actinic Keratoses Type 1 - New Molecular Entity 2012-01-23 AK Complete Clearance Rate 1005 NA Clinical No Cytotoxic Agent
VISMODEGIB NDA203388 Locally Advanced or Metastatic Basal Cell Carcinoma Type 1 - New Molecular Entity 2012-01-30 BCC Overall Response Rate 96 10 20 mRECIST No Hedgehog Inhibitor
TRAMETINIB DIMETHYL SULFOXIDE NDA204114 Unresectable or Metastatic BRAF-Mutated Melanoma Type 1 - New Molecular Entity 2013-05-29 Melanoma Progression-Free Survival 322 NA RECIST No MEK Inhibitor
DABRAFENIB MESYLATE NDA202806 Single agent, first-line in advanced BRAF-mutated melanoma Type 1 - New Molecular Entity 2013-05-29 Melanoma Progression-Free Survival 250 NA RECIST No Kinase Inhibitor
MECHLORETHAMINE HYDROCHLORIDE NDA202317 Refractory Stage IA and IB Cutaneous T-Cell Lymphoma Type 5 - New Formulation or New Manufacturer 2013-08-23 CTCL Response Rate 242 NA Composite No Alkylating Agent
TRAMETINIB DIMETHYL SULFOXIDE NDA204114 Unresectable or Metastatic BRAF-Mutated Melanoma Efficacy 2014-01-08 Melanoma Overall Survival & Progression-Free Survival 162 NA RECIST Yes MEK Inhibitor
DABRAFENIB MESYLATE NDA202806 Accelerated approval for Dab/Tram in advanced BRAF mutant melanoma Efficacy 2014-01-09 Melanoma Overall Survival & Progression-Free Survival 162 NA RECIST Yes Kinase Inhibitor
PEMBROLIZUMAB BLA125514 Unresectable or Metastatic Melanoma - Second Line Type 1 - New Molecular Entity 2014-09-04 Melanoma Overall Response Rate 173 10 mRECIST Yes PD-1 Targeted Antibody
NIVOLUMAB BLA125554 Accelerated Approval for Unresectable or Metastatic Melanoma in the Second-Line Setting Type 1 - New Molecular Entity 2014-12-22 Melanoma Overall Response Rate 120 15 RECIST Yes PD-1 Targeted Antibody
SONIDEGIB PHOSPHATE NDA205266 Locally Advanced Basal Cell Carcinoma Type 1 - New Molecular Entity 2015-07-24 BCC Overall Response Rate 194 20 mRECIST No Smoothened Inhibitor
NIVOLUMAB BLA125554 Accelerated Approval of OPDIVO with YERVOY in BRAF Wild Type Unresectable or Metastatic Melanoma Efficacy 2015-09-30 Melanoma Overall Response Rate 109 NA RECIST Yes PD-1 Targeted Antibody
TALIMOGENE LAHERPAREPVEC BLA125518 Unresectable Cutaneous, Subcutaneous, and Nodal Recurrent Melanoma Type 1 - New Molecular Entity 2015-10-27 Melanoma Durable Response Rate 436 NA WHO No Oncolytic Virus
IPILIMUMAB BLA125377 Adjuvant Melanoma Efficacy 2015-10-28 Melanoma Relapse-Free Survival 951 NA Clinical No CTLA-4 Targeted Antibody
COBIMETINIB FUMARATE NDA206192 Unresectable or Metastatic Melanoma with a BRAF-Mutated Melanoma In Combination with Vemurafenib Type 1 - New Molecular Entity 2015-11-10 Melanoma Progression-Free Survival 495 NA RECIST No Kinase Inhibitor
INGENOL MEBUTATE NDA202833 Describing response to a repeat course Efficacy 2015-11-19 AK Complete Clearance Rate 141 NA Clinical No Cytotoxic Agent
TRAMETINIB DIMETHYL SULFOXIDE NDA204114 Unresectable or Metastatic Melanoma with a BRAF-Mutated Melanoma In Combination with Dabrafenib Efficacy 2015-11-20 Melanoma Progression-Free Survival 423 NA RECIST No MEK Inhibitor
DABRAFENIB MESYLATE NDA202806 Regular approval for Dab/Tram in advanced BRAF mutant melanoma Efficacy 2015-11-20 Melanoma Overall Survival 1127 NA RECIST No Kinase Inhibitor
NIVOLUMAB BLA125554 Regular Approval for Unresectable or Metastatic BRAF-Wild Type Melanoma Efficacy 2015-11-23 Melanoma Overall Survival 418 NA RECIST No PD-1 Targeted Antibody
PEMBROLIZUMAB BLA125514 Unresectable or Metastatic Melanoma Efficacy 2015-12-18 Melanoma Progression-Free Survival & Overall Survival 540 NA mRECIST No PD-1 Targeted Antibody
PEMBROLIZUMAB BLA125514 Removing language limiting the indication to disease progression following ipilimumab Efficacy 2015-12-18 Melanoma Progression-Free Survival & Overall Survival 834 NA mRECIST No PD-1 Targeted Antibody
NIVOLUMAB BLA125554 Accelerated Approved for BRAF Mutant Unresectable or Metastatic Melanoma in the First Line Setting Efficacy 2016-01-23 Melanoma Progression-Free Survival & Overall Survival 198 NA RECIST Yes PD-1 Targeted Antibody
NIVOLUMAB BLA125554 Accelerated approval of Ipi/Nivo Expansion for BRAF mutant as well as BRAF WT Efficacy 2016-01-23 Melanoma Progression-Free Survival & Overall Survival 202 NA RECIST Yes PD-1 Targeted Antibody
AMINOLEVULINIC ACID HYDROCHLORIDE NDA208081 Actinic keratoses of mild-to-moderate severity on the face and scalp Type 3 - New Dosage Form 2016-05-10 AK Complete Response Rate 212 NA Clinical No Phototoxic Agent
NIVOLUMAB BLA125554 Flat Dosing for Melanoma, NSCLC and RCC Efficacy 2016-09-13 Melanoma NA NA NA NA No PD-1 Targeted Antibody
NIVOLUMAB BLA125554 Flat Dosing for Melanoma, NSCLC and RCC Efficacy 2016-09-13 Melanoma NA NA NA NA No PD-1 Targeted Antibody
AVELUMAB BLA761049 Metastatic Merkel Cell Carcinoma Type 1 - New Molecular Entity 2017-03-23 MCC Overall Response Rate 88 20 RECIST Yes PD-L1 Targeted Antibody
PEMBROLIZUMAB BLA125514 Flat Dosing of 200 mg q3 weeks in melanoma Efficacy 2017-05-17 Melanoma NA NA NA NA No PD-1 Targeted Antibody
PEMBROLIZUMAB BLA125514 Unresectable or Metastatic, Microsatellite Instability-High or Mismatch Repair Deficient Solid Tumors Efficacy 2017-05-23 Agnostic Overall Response Rate & Duration of Response 149 NA mRECIST Yes PD-1 Targeted Antibody
IPILIMUMAB BLA125377 Unresectable or Metastatic Melanoma - patients 12 years and older Efficacy 2017-07-21 Melanoma Pharmacokinetic Analysis 45 NA PK No CTLA-4 Targeted Antibody
BRENTUXIMAB VEDOTIN BLA125388 CD30+ MF and pcALCL in the second line Efficacy 2017-11-09 CTCL Durable Response Rate 128 NA GRS No CD30 Targeted Antibody
NIVOLUMAB BLA125554 Regular Approval for Adjuvant Melanoma Efficacy 2017-12-20 Melanoma Relapse-Free Survival 906 NA Clinical No PD-1 Targeted Antibody
NIVOLUMAB BLA125554 Updates infusion from 60 to 30 minutes Efficacy 2018-01-09 Melanoma NA NA NA NA No PD-1 Targeted Antibody
COBIMETINIB FUMARATE NDA206192 Updates label to include OS data Efficacy 2018-01-26 Melanoma NA NA NA NA NA Kinase Inhibitor
NIVOLUMAB BLA125554 Every 4 Week Dosing for Advanced Melanoma Efficacy 2018-03-05 Melanoma Pharmacokinetic Analysis 4166 NA PK No PD-1 Targeted Antibody
NIVOLUMAB BLA125554 Every 4 week dosing in Adjuvant Melanoma Efficacy 2018-03-05 Melanoma NA NA NA NA No PD-1 Targeted Antibody
NIVOLUMAB BLA125554 Updates infusion from 60 to 30 minutes in adjuvant Melanoma Efficacy 2018-03-05 Melanoma NA NA NA NA No PD-1 Targeted Antibody
AMINOLEVULINIC ACID HYDROCHLORIDE NDA020965 Minimally to moderately thick Actinic Keratosis of the upper extremities Efficacy 2018-03-06 AK Complete Response Rate 269 NA NA No Phototoxic Agent
TRAMETINIB DIMETHYL SULFOXIDE NDA204114 Adjuvant BRAF Mutant Melanoma In Combination with Dabrafenib Efficacy 2018-04-30 Melanoma Relapse-Free Survival 870 NA Clinical No MEK Inhibitor
DABRAFENIB MESYLATE NDA202806 Adjuvant BRAF Mutant Melanoma In Combination with Trametinib Efficacy 2018-04-30 Melanoma Relapse-Free Survival 870 NA Clinical No Kinase Inhibitor
ENCORAFENIB NDA210496 Regular Approval for use in combination with binimetinib for advanced BRAF mutant melanoma Type 1 - New Molecular Entity and Type 4 - New Combination 2018-06-27 Melanoma Progression-Free Survival 577 NA RECIST No Kinase Inhibitor
BINIMETINIB NDA210498 Unresectable or Metastatic BRAF-Mutated Melanoma In Combination with Encorafenib Type 1 - New Molecular Entity and Type 4 - New Combination 2018-06-27 Melanoma Progression-Free Survival 577 NA RECIST No Kinase Inhibitor
MOGAMULIZUMAB-KPKC BLA761051 Relapsed/Refractory Mycosis Fungoides or Sezary Syndrome - Second Line Type 1 - New Molecular Entity 2018-08-08 CTCL Progression-Free Survival 372 NA GRS No CCR4 Targeted Antibody
CEMIPLIMAB-RWLC BLA761097 Locally Advanced or Metastatic Squamous Cell Carcinoma Type 1 - New Molecular Entity 2018-09-28 SCC Overall Response Rate 108 15 25 Composite No PD-1 Targeted Antibody
PEMBROLIZUMAB BLA125514 Locally Advanced or Metastatic Merkel Cell Carcinoma Efficacy 2018-12-19 MCC Overall Response Rate & Duration of Response 50 NA RECIST Yes PD-1 Targeted Antibody
VISMODEGIB NDA203388 To allow for treatment interruptions of up to 8 weeks for intolerable AEs Efficacy 2019-01-18 BCC NA NA NA NA No Hedgehog Inhibitor
PEMBROLIZUMAB BLA125514 Adjuvant Melanoma Efficacy 2019-02-15 Melanoma Relapse-Free Survival 1019 NA Clinical No PD-1 Targeted Antibody
NIVOLUMAB BLA125554 Conversion to Regular Approval for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma Efficacy 2019-03-07 Melanoma Overall Survival 405 NA NA No PD-1 Targeted Antibody
NIVOLUMAB BLA125554 Conversion to Regular Approval of OPDIVO, in combination with ipilimumab, for the treatment of patients with unresectable or metastatic melanoma Efficacy 2019-03-07 Melanoma Overall Survival 945 NA Clinical No PD-1 Targeted Antibody
TRAMETINIB DIMETHYL SULFOXIDE NDA204114 Updating results in subjects with brain metastases Efficacy 2019-10-06 Melanoma Overall Response Rate 121 NA mRECIST No MEK Inhibitor
DABRAFENIB MESYLATE NDA202806 Updates label in regards to brain mets for melanoma Efficacy 2019-10-06 Melanoma Overall Response Rate 121 NA mRECIST No Kinase Inhibitor
PEMBROLIZUMAB BLA125514 Every 6 weeks dosing in Melanoma Efficacy 2020-04-28 Melanoma Pharmacokinetic Analysis 44 NA PK Yes PD-1 Targeted Antibody
PEMBROLIZUMAB BLA125514 Every 6 weeks dosing in Merkel Cell Carcinoma Efficacy 2020-04-28 MCC NA NA NA NA Yes PD-1 Targeted Antibody
PEMBROLIZUMAB BLA125514 Every 6 weeks dosing in MSI-H tumors Efficacy 2020-04-28 Agnostic NA NA NA NA Yes PD-1 Targeted Antibody
POMALIDOMIDE NULL Treatment of adult patients with AIDS-related Kaposi sarcoma Efficacy 2020-05-14 KS Overall Response Rate 28 NA ACTG Yes Cereblon Inhibitor
POMALIDOMIDE NULL Treatment of Kaposi’s Sarcoma in patients who are HIV-negative Efficacy 2020-05-14 KS Overall Response Rate 28 NA ACTG Yes Cereblon Inhibitor
PEMBROLIZUMAB BLA125514 Tumor Mutation Burden-High Solid Tumors Efficacy 2020-06-16 Agnostic Overall Response Rate & Duration of Response 102 NA mRECIST Yes PD-1 Targeted Antibody
PEMBROLIZUMAB BLA125514 Every 6 weeks dosing in TMB-H tumors Efficacy 2020-06-16 Agnostic NA NA NA NA Yes PD-1 Targeted Antibody
PEMBROLIZUMAB BLA125514 r/mCSCC Efficacy 2020-06-24 SCC Overall Response Rate 105 15 mRECIST No PD-1 Targeted Antibody
PEMBROLIZUMAB BLA125514 Every 6 weeks dosing for CSCC Efficacy 2020-06-24 SCC NA NA NA NA Yes PD-1 Targeted Antibody
ATEZOLIZUMAB BLA761034 Unresectable or Metastatic BRAF-Mutated Melanoma In Combination with Cobimetinib and Vemurafenib Efficacy 2020-07-30 Melanoma Progression-Free Survival 514 NA RECIST No PD-L1 Targeted Antibody
TIRBANIBULIN NDA213189 Actinic keratosis of the face or scalp Type 1 - New Molecular Entity 2020-12-14 AK Complete Clearance Rate 702 NA Clinical No Microtubule Inhibitor
CEMIPLIMAB-RWLC BLA761097 Locally Advanced Basal Cell Carcinoma Efficacy 2021-02-09 BCC Overall Response Rate 112 20 Composite No PD-1 Targeted Antibody
CEMIPLIMAB-RWLC BLA761097 Metastatic Basal Cell Carcinoma Efficacy 2021-02-09 BCC Overall Response Rate 112 NA Composite Yes PD-1 Targeted Antibody