The U.S. Food and Drug Administration (FDA) has approved Iovance Biotherapeutics’ treatment lifileucel, marketed as Amtagvi, for certain patients with advanced melanoma. This decision marks a significant milestone as Amtagvi is the first individualized tumor-infiltrating lymphocyte (TIL) therapy available in the U.S.
Amtagvi is approved for adults diagnosed with unresectable or metastatic melanoma who have already been treated with a PD-1-blocking antibody, and if applicable, a BRAF inhibitor with or without a MEK inhibitor. The approval follows data from a Phase 2 study that showed a 31.5% overall response rate, including three complete responses and 29 partial responses among 73 patients. The median duration of response was 8.9 months, with many responses lasting more than a year.
Dr. Samantha Guild, president of AIM at Melanoma Foundation, commented, “This approval is a meaningful advance for the melanoma community. Patients now have another option, especially those with disease that hasn’t responded to standard therapies.”
The FDA reviewed Amtagvi through its Orphan Drug and Regenerative Medicine Advanced Therapy designations, which help accelerate the development of promising treatments. Iovance plans to gradually increase shipments across a network of authorized treatment centers with manufacturing handled at their facility in Philadelphia.
Amtagvi is administered as a one-time personalized cell therapy made by harvesting and expanding a patient’s own T cells from a tumor. These immune cells are returned to the patient to help fight the cancer.
Frederick Vogt, interim CEO of Iovance, said, “We believe Amtagvi will pave the way for cell therapy in solid tumors and offer new hope to patients with advanced melanoma who have limited treatment options.”
