"FDA Greenlights Revolutionary Cell Therapy for Advanced Melanoma"
Iovance Biotherapeutics' stock surged after the FDA granted accelerated approval to its T cell immunotherapy, Amtagvi, for treating advanced melanoma. Amtagvi is the first one-time T cell therapy approved for solid tumor cancer and the first treatment option for advanced melanoma that has progressed after prior anti-PD-1/L1 therapy. The approval addresses the unmet needs of melanoma patients and provides a significant commercial opportunity for Iovance. The company is also evaluating Amtagvi for frontline advanced melanoma and other solid tumors. However, the approval comes with a boxed warning for treatment-related risks.