FDA Approves Amtagvi as the First One-time Cell Therapy for Solid Tumors: A Groundbreaking TIL Immunotherapy for Advanced Melanoma

The U.S. Food and Drug Administration (FDA) has made a historical move by approving Amtagvi (lifileucel), the first cell therapy designed to treat solid tumors. Developed by Iovance Biotherapeutics, Amtagvi is a novel tumor-infiltrating lymphocyte (TIL) therapy intended for patients with unresectable or metastatic melanoma who have exhausted other treatment options, specifically after a prior course of a PD-1 inhibitor.

- Amtagvi is the first individualized TIL therapy approved for a solid tumor, specifically melanoma.
- The therapy harvests and expands the patient's own TIL cells, which have a natural ability to identify and fight cancer cells, before being reinfused back into the patient.
- The FDA granted Amtagvi an accelerated approval, allowing for faster access to therapies targeting serious conditions while requiring further trials to confirm efficacy.
- Phase 2 clinical trial (C-144-01) demonstrated a 31% response rate in 153 patients, with 42% of responses lasting for more than 18 months.
- Amtagvi has a wholesale acquisition cost of $515,000 per patient and is priced slightly higher than existing CAR-T therapies for blood cancers.
- The treatment comes with a boxed warning for treatment-related deaths, prolonged severe cytopenia, severe infection, and cardiopulmonary and kidney impairment.

Amtagvi represents a breakthrough in the treatment of solid tumors, signaling a significant expansion of cell therapy beyond blood cancers. The therapy aims to improve outcomes for melanoma patients with limited options following initial standard of care.