SAN CARLOS, Calif. - Iovance Biotherapeutics, Inc. (NASDAQ: NASDAQ:IOVA), a biotechnology firm specializing in cancer treatments, announced the FDA approval of AMTAGVI™ (lifileucel) for advanced melanoma patients. This marks the first FDA-approved T cell therapy for solid tumor cancer, providing a new treatment option for melanoma patients after initial therapies.
AMTAGVI is designed for adults with unresectable or metastatic melanoma that has progressed despite prior treatment with a PD-1 blocking antibody and, if applicable, targeted therapy. The treatment leverages a patient's own tumor-infiltrating lymphocytes (TILs), which are expanded and reinfused to combat cancer.
The FDA's accelerated approval is based on the overall response rate (ORR) and duration of response observed in the C-144-01 clinical trial. In this study, 31.5% of patients achieved an objective response, with many responses lasting over 12 months. The trial's results are published in The Journal for ImmunoTherapy of Cancer.
Iovance's interim CEO, Frederick Vogt, Ph.D., J.D., expressed the company's commitment to expanding novel cell therapies for solid tumor cancers. The approval of AMTAGVI offers a one-time, personalized therapeutic option for advanced melanoma patients, addressing a significant unmet need.
AMTAGVI's administration will occur at Authorized Treatment Centers (ATCs), with over 30 centers ready to process and ship tumor tissue for manufacturing. The Iovance Cell Therapy Center (iCTC) in Philadelphia, a dedicated facility for TIL cell therapy production, will handle manufacturing, with plans to increase capacity in the coming years.
The company is also conducting the TILVANCE-301 Phase 3 confirmatory trial for AMTAGVI and investigating its application in additional solid tumor types.
This article is based on a press release statement from Iovance Biotherapeutics, Inc.
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