"FDA Greenlights Revolutionary Cell Therapy for Advanced Melanoma"
TL;DR Summary
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.
Topics:business#amtagvi#businesshealthcare#fda-approval#iovance-biotherapeutics#melanoma-treatment#t-cell-immunotherapy
- Iovance (IOVA) Stock Rises on FDA Nod for Melanoma Drug Amtagvi Yahoo Finance
- FDA approves first T-cell therapy for a solid tumor FiercePharma
- FDA approves first cell therapy to treat aggressive forms of melanoma NPR
- FDA approves groundbreaking treatment for advanced melanoma NBC News
- FDA Approves First Cellular Treatment For Advanced Melanoma Forbes
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