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Iovance's Groundbreaking AMTAGVI™ (Lifileucel) Secures Accelerated FDA Approval to Revolutionize Advanced Melanoma Therapy

Iovance Biotherapeutics has gained approval from the U.S. Food and Drug Administration (FDA) for AMTAGVI™ (lifileucel) suspension for intravenous infusion. This treatment is tailored for adults facing unresectable or metastatic melanoma and who have previously received treatment with a PD-1 blocking antibody. Additionally, if patients test positive for the BRAF V600 mutation, they may also have received a BRAF inhibitor with or without a MEK inhibitor.

The FDA's approval was based on overall response rate (ORR) and duration of response, leading to accelerated approval. AMTAGVI marks a significant advancement as the first individualized T cell therapy to gain FDA approval for solid tumor cancer.

The therapy leverages patient-specific T cells called TIL cells, which are naturally produced by the immune system to target and eliminate cancer cells. AMTAGVI collects and expands a patient's unique T cells from a portion of their tumor, reintroducing billions of these cells back into the body to combat cancer.

AMTAGVI is administered at Authorized Treatment Centers (ATCs) as part of a comprehensive treatment regimen involving lymphodepletion and a short course of high-dose PROLEUKIN® (aldesleukin). It's important to note that AMTAGVI carries significant warnings, including treatment-related mortality, prolonged severe cytopenia, severe infection, and cardiopulmonary and renal impairment.

The therapy is intended for autologous use and prescribed for adults with unresectable or metastatic melanoma that has not responded to PD-1 blocking drugs alone or in combination, as well as BRAF mutation positive melanomas that have ceased to respond to BRAF inhibitor drugs with or without MEK inhibitor drugs. The approval of AMTAGVI signifies a notable milestone in the field of cell therapy, reflecting Iovance's dedication to advancing treatments for patients with advanced solid tumors.

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