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SAN CARLOS, California – Iovance Biotherapeutics, Inc. (NASDAQ: NASDAQ:), a biotechnology company focused on cancer treatments, announced the FDA approval of AMTAGVI™ (lifileucel) for patients with advanced melanoma. This is the first FDA-approved T-cell therapy for solid tumor cancer, providing a new treatment option for patients with melanoma 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 takes advantage of the patient’s own tumor-infiltrating lymphocytes (TILs), which are expanded and reinfused to fight the 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, many of which lasted longer than 12 months. The results of the study are published in the Journal for ImmunoTherapy of Cancer.
Iovance’s interim CEO, Frederick Vogt, Ph.D., JD, expressed the company’s commitment to expanding novel cell therapies for solid tumors. The approval of AMTAGVI provides a personalized, one-time treatment option for patients with advanced melanoma, addressing an important unmet need.
Administration of AMTAGVI will take place at Authorized Treatment Centers (ATCs), with more than 30 centers ready to process and ship tumor tissue for manufacturing. The Iovance Cell Therapy Center (iCTC) in Philadelphia, a facility dedicated to manufacturing TIL cell therapies, will handle manufacturing, with plans to increase capacity in the coming years.
The company is also conducting the confirmatory Phase 3 TILVANCE-301 study for AMTAGVI and investigating its application in other types of solid tumors.
This article is based on a press release from Iovance Biotherapeutics, Inc.
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