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LAUNCH ALERT: Lifileucel (AMTAGVI) Approved for Treatment of Advanced Melanoma

FDA grants accelerated approval for the first T cell therapy for a solid tumor cancer

By Dermsquared Editorial Team | February 22, 2024

Iovance Biotherapeutics, Inc, has achieved a significant milestone with the FDA approval of its revolutionary T cell therapy, AMTAGVI (lifileucel). This therapy marks the first FDA-approved T cell treatment for solid tumor cancer, specifically addressing advanced melanoma following anti-PD-1 and targeted therapy. 

AMTAGVI utilizes tumor-infiltrating lymphocytes (TIL) to recognize and combat cancer. The treatment, administered through intravenous infusion, is a one-time, individualized T cell therapy, making it a unique and personalized approach for patients. 

The therapy is designed for adult patients with unresectable or metastatic melanoma who have previously received PD-1 blocking antibody treatment, and if BRAF V600-mutation positive, a BRAF inhibitor with or without a MEK inhibitor. 

Clinical trial insights 

Accelerated approval by the FDA was supported by results from the C-144-01 trial, a global, multicenter Phase 2 study that enrolled patients with metastatic melanoma who had been previously treated with at least one systemic therapy, including a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor or BRAF inhibitor with MEK inhibitor. 

Approval was supported by the overall response rate and duration of response seen in clinical trials, and ongoing trials, such as TILVANCE-301, aim to confirm its clinical benefits. 

Mechanism of action 

AMTAGVI is manufactured using a proprietary process to collect and expand a patient’s unique T cells from a portion of their tumor. AMTAGVI returns billions of the patient’s T cells back to the body to fight their cancer. The specific mechanism of action is unknown. 

Safety profile 

Safety considerations include warnings for treatment-related mortality, prolonged severe cytopenia, severe infection, and cardiopulmonary and renal impairment. 

Future outlook 

AMTAGVI will be manufactured in Philadelphia at the Iovance Cell Therapy Center, with plans for significant expansion to accommodate more patients in the coming years. The therapy will be administered in Authorized Treatment Centers (ATCs), and over 30 ATCs are prepared to collect and ship tumor tissue for AMTAGVI manufacturing.


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