BioPharmaPT
โ† All oncology drugs

Melanoma

Oncologyยท 8 reviewed drugsยท 49392 cited findings behind them

What the regulatory reviews cover

This library contains regulatory review documents for several drugs indicated for melanoma. Yervoy is indicated for the treatment of unresectable or metastatic melanoma in adults and pediatric patients 12 years and older, with an overall survival of 10 months. Tafinlar, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, showed a median progression-free survival of 6.9 months compared to 2.7 months for the comparator.

Zelboraf, for newly diagnosed or recurrent histologically confirmed surgically incurable and unresectable stage IIIc or stage IV melanoma, demonstrated an overall survival of 13.2 months compared to 9.6 months for dacarbazine. Opdualag, for the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older, reported a median PFS of 10.15 months. Kimmtrak / tebentafusp, for HLA A*02:01 positive adult patients with unresectable or metastatic uveal melanoma, showed a median overall survival for single-agent chemotherapy in mUM of 10. Different drugs were studied in different trials, so figures are not head-to-head.

The drugs โ€” one cited result each

Keytruda

Merck & Co., Inc.

24441 cited findings on the drug page โ†’
Opdivo

Bristol-Myers Squibb Company

17346 cited findings on the drug page โ†’
Yervoy

Bristol-Myers Squibb Company

overall survival: 10 months

BRISTOL MYERS SQUIBB โ€” Yervoy FDA Review (NDA/BLA 125377, 20, p.67

Tafinlar

Novartis AG

Median progression-free survival (months): 6.9

Novartis AG โ€” Tafinlar EMA EPAR public assessment report (EM, p.92

Opdualag

Bristol-Myers Squibb Company

Median PFS (months): 10.15

Bristol-Myers Squibb Company โ€” Opdualag EMA EPAR public asse, p.82

Zelboraf

Roche Holding AG

Overall survival (vemurafenib): 13.2 months

EMA EPAR, p.55

Kimmtrak / tebentafusp

Immunocore

Median overall survival for single-agent chemotherapy in mUM: 10

Immunocore โ€” Kimmtrak EMA EPAR public assessment report (EME, p.10

Cotellic

Roche Holding AG

median PFS (months): 12.3

GENENTECH INC โ€” Cotellic FDA Summary Review (NDA/BLA 206192,, p.3

Different drugs were studied in different trials โ€” these figures are not head-to-head comparisons.

Explore the full evidence

Every finding behind these drugs โ€” searchable, comparable and answerable in plain language โ€” is in the Oncology research library โ†’

Lists reflect the regulatory review documents in this library, not all therapies that exist. Educational reference only โ€” not medical or investment advice.

Melanoma โ€” 8 Drugs, FDA & EMA Review Findings | BioPharmaPT Oncology