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FDA Accelerated Approval: AMTAGVI  (Catapult’s regulatory round-up – february 2024)

The FDA has issued an accelerated BLA approval of lifileucel (AMTAGVI), a tumor-derived autologous T cell immunotherapy, 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.

Published on the 5th of March 2024 in Catapult’s regulatory round-up for february 2024.


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (5 novembre 2024). FDA Accelerated Approval: AMTAGVI  (Catapult’s regulatory round-up – february 2024). ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/12mid


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