Iovance Biotherapeutics, a leading biotechnology company committed to pioneering, developing, and delivering innovative polyclonal tumor infiltrating lymphocyte (TIL) cell therapies for cancer patients, has announced the approval of AMTAGVI™ (lifileucel) suspension for intravenous infusion by the U.S. Food and Drug Administration (FDA). AMTAGVI is designed to serve as a tumor-derived autologous T cell immunotherapy for adult patients dealing with unresectable or metastatic melanoma, especially those who have previously received treatment with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. This approval, which is based on accelerated approval criteria focusing on overall response rate (ORR) and duration of response, marks a significant milestone for Iovance.
Simultaneously, the company is conducting TILVANCE-301, a Phase 3 trial aimed at confirming the clinical benefit of AMTAGVI. AMTAGVI stands as the first one-time, personalized T cell therapy to receive FDA approval for the treatment of solid tumor cancer. Its proposed mechanism introduces an innovative cell therapy approach that harnesses patient-specific TIL cells, which are activated by the immune system upon cancer detection to target and eliminate cancer cells by recognizing unique tumor markers.
AMTAGVI is manufactured using a proprietary process to harvest and amplify a patient’s distinctive T cells from a segment of their tumor. Billions of these patient-specific T cells are reintroduced into the body to combat the cancer. The administration of AMTAGVI, including lymphodepletion and a brief high-dose PROLEUKIN® regimen, will be overseen by Authorized Treatment Centers (ATCs) as part of the treatment protocol.
The accelerated approval of AMTAGVI™ represents a significant advancement toward Iovance's goal of advancing the next generation of cell therapy, offering hope to individuals with advanced solid tumors, particularly those with advanced melanoma who have exhausted standard treatment options. Recognizing the critical need for access, Iovance is committed to facilitating AMTAGVI availability for patients with advanced melanoma through its comprehensive support program, IovanceCares™, which provides a range of assistance throughout the treatment journey, including copay support, financial assistance, and travel and lodging aid for eligible patients undergoing AMTAGVI therapy.
