The U.S. FDA has granted accelerated approval to Iovance Biotherapeutics' Amtagvi (lifileucel), marking the first T-cell therapy for a solid tumor cancer and the first treatment option for advanced melanoma after anti-PD-1 and targeted therapy.
Amtagvi is a patient-specific, one-time immunotherapy utilizing T-cells to target and combat cancer cells. It is indicated for adult patients with unresectable or metastatic melanoma who have previously received treatment with a PD-1 blocking antibody and, if applicable, a BRAF inhibitor with or without a MEK inhibitor. The approval is based on promising overall response rates and duration of response observed in clinical trials.
This treatment process involves collecting and expanding a patient's unique T-cells from a portion of their tumor, which are then infused back into the body to fight the cancer.
Iovance was initially given a target action date of November 25, 2023, but in September, the FDA asked for more time in order to provide a response to an information request for the BLA review ahead of its review meeting.
The FDA's decision is on positive safety and efficacy results demonstrated in the global, multicenter C-144-01 clinical trial, which showed deep and durable responses in patients with advanced melanoma.
