METASTATIC MELANOMA THERAPEUTICS MARKET ANALYSIS

Key Developments

• On February 16, 2024, the U.S. Food and Drug Administration (FDA) approved Amtagvi (lifileucel), marking the first cellular therapy sanctioned for treating adults with unresectable or metastatic melanoma. This type of skin cancer, which is challenging to treat and can be life-threatening, typically requires prior treatment with a PD-1 blocking antibody and, if the cancer is BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.
• In July 2022, Bristol-Myers Squibb Company, a global biopharmaceutical company, reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had recommended the approval of the combined use of nivolumab and relatlimab for the initial treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents aged 12 and older.
• In March 2022, Nektar Therapeutics, a U.S.-based biopharmaceutical company, and Bristol Myers Squibb Company provided an update after the initial analysis of the Phase 3 PIVOT IO-001 study, which assessed the combination therapy of bempegaldesleukin with Opdivo (nivolumab) versus Opdivo alone as a first-line treatment for previously untreated unresectable or metastatic melanoma.
• In January 2022, Pfizer Inc., a multinational pharmaceutical and biotechnology corporation, obtained approval from the U.S. Food and Drug Administration (FDA) for CIBINQO (abrocitinib), an oral JAK1 inhibitor taken once daily. It is indicated for adults with refractory, moderate-to-severe atopic dermatitis (AD) whose condition is inadequately controlled by other systemic medications, including biologics, or when their use is not advisable.
• In January 2022, Immunocore, a commercial-stage biotechnology company, received U.S. FDA approval for KIMMTRAK (tebentafusp-tebn) to treat unresectable or metastatic uveal melanoma