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FDA Approves AMTAGVI for Advanced Melanoma

WuXi Advanced Therapies receives approval for its Philadelphia site to begin the analytical testing and manufacture of AMTAGVI for Iovance.

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By: Kristin Brooks

Managing Editor, Contract Pharma

Iovance Biotherapeutics, Inc., a biotechnology company developing polyclonal tumor infiltrating lymphocyte (TIL) cell therapies for cancer, received approval from the U.S. FDA for AMTAGVI (lifileucel) suspension for intravenous infusion. AMTAGVI is a tumor-derived autologous T cell immunotherapy for the treatment of adults with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor...

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