A week ahead of schedule, the FDA approved the nation's first cell therapy for advanced melanoma on Feb. 16.
The drug, Iovance Biotherapeutics' Amtagvi, is a tumor-derived autologous T cell immunotherapy that expands a patient's own T cells to fight the cancer.
The medicine is indicated for unresectable or metastatic melanoma, which is when the cancer cannot be removed surgically or spreads to other body parts. Melanoma is a rare form of skin cancer that accounts for a significant number of cancer-related deaths, the FDA said.
Amtagvi (lifileucel) is the first approved drug for treating solid tumor cancer, Iovance said in a news release.