Nicole Verdun: We granted accelerated approval for Amtagvi (lifileucel), manufactured by Iovance Biotherapeutics

Nicole Verdun, Super Office Director at FDA, recently posted on LinkedIn:

“I am pleased to announce that Friday we granted accelerated approval for Amtagvi (lifileucel), manufactured by Iovance Biotherapeutics, Inc. Amtagvi is the first FDA-approved tumor-derived T cell immunotherapy. Amtagvi is composed of the patients’ own T cells. Tumor tissue is removed from the patient during a surgical procedure prior to treatment. The patients’ T cells are separated from the tumor tissue, further manufactured, and then returned to the same patient. Amtagvi is 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 is positive, a BRAF inhibitor with or without a MEK inhibitor.

I want to express my appreciation for the review committee at the FDA and for all of your continued support of the Office of Therapeutic Products. We look forward to continuing the work of getting novel therapies to patients with significant unmet needs.”

Source: Nicole Verdun/LinkedIn