FDA approves Iovance’s Amtagvi as first T-cell therapy for a solid tumor

Fierce Pharma February 17, 2024
Angus Liu

The T-cell therapy treatment class, which has transformed the treatment of certain blood cancers, has now reached the solid tumor field thanks to an FDA approval for a first-of-its-kind immunotherapy developed by Iovance Biotherapeutics.

Called Amtagvi, or lifileucel, the drug is the first individualized tumor-infiltrating lymphocyte (TIL) therapy to reach the market. The FDA on Friday granted it an accelerated approval for patients with advanced melanoma following prior treatment with a PD-1 inhibitor—and a BRAF inhibitor if the tumor carries BRAF V600 mutation.

Iovance is pricing the one-time treatment at a wholesale acquisition cost of $515,000 per patient, the company’s interim CEO Frederick Vogt, Ph.D., said on a call following Friday’s approval.

The drug’s list price is slightly higher than...

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