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The FDA approved the cellular therapy lifileucel (Amtagvi) for the treatment of patients with previously treated unresectable or metastatic melanoma, the Friday.

Lifileucel, a cellular therapy with tumor-infiltrating lymphocytes (TILs), was approved through the accelerated approval pathway, and is the first FDA-approved tumor-derived T-cell immunotherapy, the FDA noted.

"Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal," said Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research. "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."

Approval was based on a global, multicohort phase II trial, which included adult patients with unresectable or metastatic melanoma who had previously been treated with at least one systemic therapy, including a PD-1-blocking antibody, and if positive for the BRAF V600 mutation, a BRAF inhibitor with or without a MEK inhibitor.

Among the 73 patients treated with lifileucel at the recommended dose, 23 achieved an objective response, including three complete responses and 20 partial responses.

Among patients who were responsive to the treatment, 56.5%, 47.8%, and 43.5% continued to maintain responses without tumor progression or death at 6, 9, and 12 months, respectively.

"One-time treatment with Amtagvi offered clinically meaningful and deep, durable responses in the phase II clinical trial, and I am excited by its potential as a much-needed new treatment option for the many advanced melanoma patients who progress on the current standard of care," said Alexander N. Shoushtari, MD, of Memorial Sloan Kettering Cancer Center in New York City, in a , the therapy's developer.

The most common adverse reactions associated with lifileucel include chills, fever, fatigue, tachycardia, diarrhea, febrile neutropenia, edema, rash, hypotension, hair loss, infection, hypoxia, and shortness of breath.

Lifileucel has a boxed warning for prolonged severe low blood count, severe infection, cardiac disorder, the development of worsening respiratory or renal function, and fatal treatment-related complications.

A confirmatory trial is ongoing to verify lifileucel's clinical benefit.

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