Iovance’s Amtagvi gets FDA accelerated approval for advanced melanoma

The US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Amtagvi (lifileucel) suspension for intravenous infusion, submitted by US biotech Iovance Biotherapeutics (Nasdaq: IOVA), sending the firm’s shares up almost 33% to $12.13 in after-hours trading on Friday.

Amtagvi is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.

This indication, which comes a week ahead of the expected decision date, is approved under an accelerated approval based on overall response rate (ORR) and duration of response. Iovance is also conducting TILVANCE-301, a Phase III trial to confirm clinical benefit.