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FDA Approves Iovance's TIL Therapy Amtagvi for Melanoma, Marking First Cell Therapy for Solid Tumors

NEW YORK – The US Food and Drug Administration on Friday approved Iovance Biotherapeutics' autologous tumor-infiltrating lymphocyte (TIL) therapy Amtagvi (lifileucel) for previously treated patients with unresectable or metastatic melanoma.

This makes Amtagvi the first autologous TIL therapy to gain approval in the US. The accelerated approval was based on data from the Phase II C-144-01 clinical trial, which demonstrated an overall response rate of 31.5 percent within a cohort of 73 melanoma patients. At 18.6 months follow-up, the median duration of response was not reached in this cohort. Pooled data from 153 patients in two cohorts of the C-144-01 clinical trial showed similar responses.

"This landmark FDA approval reflects significant advancements in TIL cell therapy since we initially showed that TIL cells isolated from patients with metastatic melanoma could be expanded in the lab and returned to the patient to mediate cancer regression," Steven Rosenberg, chief of the surgery branch at the National Cancer Institute, said in a statement. "This approval is transformative for the entire research field and supports continued investigation of TIL cell therapy across additional types of solid tumors."

The FDA's decision was initially expected last November, but the regulator extended its deadline to review the biologics license application for Amtagvi in September, saying it had insufficient resources to review the application. Iovance also faced hurdles to this approval, repeatedly having to push back its lifileucel submission for approval due to FDA feedback.

The agency has taken steps to streamline its review of cell and gene therapies due to the unique development and treatment processes of these treatments. Last month, the FDA issued a draft guidance detailing how it will ensure a cell therapy product's potency, which was aimed to help drugmakers understand how it will measure the reliability of these products.

Iovance has already begun a Phase III confirmatory trial for Amtagvi in this setting, TILVANCE-301, which began enrolling patients last June. The firm is also studying Amtagvi as a treatment for non-small cell lung cancer, but that trial was put on hold in December after a patient death.