Keeping Track: Iovance’s Amtagvi Approval Brings T Cell Therapy To Solid Tumors

Iovance Biotherapeutics, Inc.'s polyclonal tumor infiltrating lymphocyte (TIL) cell therapy Amtagvi (lifileucel) worked its way through the US Food and Drug Administration’s Center for Biologics Evaluation and Research, emerging on 16 February with the first approval of an autologous T cell immunotherapy for a solid tumor cancer.

Amtagvi received accelerated approval for 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 – a setting where the TIL therapy is