On February 16, 2024, the U.S. FDA approved the first adoptive tumour-infiltrating lymphocyte (TIL) T cell therapy, Amtagvi (lifileucel). This is a significant step in oncology, as the first FDA-approved tumor-derived T cell immunotherapy is Amtagvi (lifileucel), a unique treatment option for patients with advanced, incurable, or metastatic melanoma. Amtagvi (lifileucel) was approved through the FDA’s Accelerated Approval Program, under which the FDA may approve drugs for serious or life-threatening illnesses or conditions where there is an unmet medical need. Furthermore, the drug was granted fast-track designation, priority review, Regenerative Medicine Advanced Therapy (RMAT) designation, and orphan drug designation.
The FDA approved Amtagvi for Iovance Biotherapeutics Inc., and WuXi Advanced Therapies was given manufacturing approval. This is an example of a developer and a Contract Development and Manufacturing Organization (CDMO) working together to create a customized T-cell therapy for solid tumors.
Miguel Forte, MD, PhD, the next president of ISCT, commented on the implications of this approval for patients, saying, “Industry analysts have estimated that up to 500 patients could receive treatment this year, which marks a positive step for patients with advanced melanoma. It is important to note that the target price of Amtagvi (lifileucel) at $515,000 USD aligns with the price of other oncology cell therapies, such as engineered CAR-Tsand all stakeholders should continue to make further efforts to ensure broader patient access in the landscape of these groundbreaking transformative therapies.”
ISCT is dedicated to finding answers to the problems involved in turning promising technology into patient-accessible, safe, and effective therapeutics. TILs remain to be an important area of focus within ISCT. The ISCT Immuno-Gene Therapy Committee is working on a publication on cytotherapy that will address significant manufacturing and regulatory obstacles to the widespread use of TIL-based therapeutics.
Cell Therapy, TIL, FDA