FDA Approves First One-time Cell Therapy for a Solid Tumor

Published: Feb 16, 2024 By Aayushi Pratap and Heather McKenzie

Friday, the FDA granted approval to Iovance Biotherapeutics’ lifileucel as the first one-time cell therapy for a solid tumor and the first tumor-infiltrating lymphocytes (TIL) therapy.

Amtagvi, as lifileucel will be known commercially, was approved under the FDA's Accelerated Approval pathway, which allows the greenlighting of medicines for serious or life-threatening diseases based on surrogate endpoints that are reasonably likely to predict clinical benefit.

“The approval of Amtagvi represents the culmination of scientific and clinical research efforts leading to a novel T cell immunotherapy for patients with limited treatment options," Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

Each year, approximately 8,000 people in the U.S. die from melanoma, according to Iovance's approval announcement. “The approval of Amtagvi offers hope to those with advanced melanoma who have progressed following initial standard of care therapies, as the current treatment options are not effective for many patients,” Samantha R. Guild, president of AIM at Melanoma Foundation, said in the same press release.

Amtagvi is approved for autologous use only and carries a boxed warning for treatment-related mortality, prolonged severe cytopenia, severe infection, and cardiopulmonary and renal impairment.

Speaking with BioSpace ahead of the approval, experts said it would give the space much-needed momentum.

“It has taken a long time, but an approval would clearly validate the progress the field is making, and we expect that to increase from here rapidly,” Lynn Seely, CEO of Lyell, a clinical-stage company developing TIL and CAR-T therapies, told BioSpace.

40 Years in the Making

TIL technology has taken nearly four decades to reach maturity. The method was developed by Steven Rosenberg and colleagues at the National Cancer Institute in 1982 using mouse cells; they applied the method to melanoma patients in 1988, and the treatment has shown great efficacy in treating advanced melanoma in animal research and clinical trials.