‘Significant Milestone’ Brings New Weapon to Advanced Melanoma Fight

The FDA recently approved a first-in-class agent to treat a particularly deadly cancer. The therapy, Iovance Biotherapeutics, Inc.’s Amtagvi (lifileucel), signifies a promising new development in the treatment of solid tumors, which represent about 90% of all cancers in the U.S. While the drug comes with a price tag of more than $500,000, as well as additional costs, payers’ experience with chimeric antigen receptor T cells (CAR-T) therapies should be helpful in their coverage of the new agent, say industry sources.

On Feb. 16, the FDA gave accelerated approval to Amtagvi for the treatment of adults with unresectable or metastatic melanoma previously treated with a programmed death receptor-1 (PD-1) inhibitor and, if BRAF V600 positive, a BRAF inhibitor with or without a MEK inhibitor. The agency gave the therapy orphan drug, regenerative medicine advanced therapy, fast track and priority review designations.

© 2024 MMIT
Angela Maas

Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. She also has written for Spotlight on Market Access since its 2017 launch. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at Hem Aware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.

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