WuXi Advanced Therapies (WuXi ATU), a wholly owned subsidiary of WuXi AppTec (SHA: 603259, HKG: 2359) based in China, has announced the U.S. FDA’s approval of its Philadelphia facility to commence analytical testing and manufacturing of Amtagvi (lifileucel) for Iovance. This novel therapy received accelerated approval for its Biologics License Application (BLA) on February 16, 2024.
Amtagvi is an autologous T cell immunotherapy derived from tumors, indicated for adult patients with unresectable or metastatic melanoma who have previously been treated with a PD-1 blocking antibody, and for those with a BRAF V600 mutation, a BRAF inhibitor with or without a MEK inhibitor. Notably, it is the first and only one-time, individualized T cell therapy to gain FDA approval for a solid tumor cancer indication.
Iovance (NASDAQ: IOVA), headquartered in San Carlos, California, operates the FDA-approved Iovance Cell Therapy Center (iCTC), which is custom-built for cell manufacturing and adjacent to WuXi ATU in the Navy Yard Philadelphia.- Flcube.com
