Iovance Biotherapeutics, Inc., a biotechnology company focused on the innovation, development and distribution of polyclonal tumor-infiltrating lymphocyte (TIL) cell therapies for cancer patients, has received approval from the US Food and Drug Administration (FDA) for Amtagvi (lifileucel) announced completely.
Infusion Amtagvi is indicated for the treatment of adult patients with unresectable or metastatic melanoma who have been previously treated with an anti-PD-1 antibody and in those who have been treated with a non-inhibitor BRAF inhibitor. MEK if positive for BRAF V600 mutation. Autologous T cell immunotherapy. This indication was approved under accelerated approval based on the overall response rate (ORR) and duration of response. Iovance also conducts a Phase 3 clinical trial, TILVANCE-301, to confirm clinical benefit.
Amtagvi is the first and only FDA-approved individual T-cell therapy for solid lung cancer. The proposed method for Amtagvi offers a new cell therapy approach that provides patient-specific T cells called TIL cells. When cancer is detected, the immune system produces TIL cells to find, attack and destroy the cancer. TIL cells recognize the unique tumor markers on the surface of each individual's cancer cells. Once cancer develops and spreads, the body's natural TIL cells can no longer fight the cancer.
Amtagvi is made using a proprietary technique that collects and expands single T cells from a section of a patient's tumor. Amtagvi returns billions of the patient's T cells to the body to fight cancer. Authorized treatment centers (ATCs) prescribe Amtagvi to patients as part of a treatment regimen that includes short-term lymphocyte depletion and proleucine (aldesleucine).
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