FDA Approves First Cellular Therapy for Metastatic Melanoma

The FDA has approved lifileucel for the treatment of certain adults with unresectable or metastatic melanoma, marking the first approval of a cellular therapy in the solid tumor setting. The tumor-derived autologous T-cell immunotherapy is indicated for patients previously treated with a PD-1–blocking antibody, and if BRAF V600–positive, a BRAF inhibitor with or without an MEK inhibitor. The approval was based on findings from a clinical trial showing an objective response rate of 31.5% in patients treated with lifileucel. The full prescribing information contains a boxed warning for treatment-related mortality and other risks. The therapy will be available at Stanford Medicine immediately. Monitoring for adverse reactions is crucial. Sharon Worcester is the author of the content.

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