FDA Approves Gilead CAR-T Therapy Yescarta, Plans Regenerative Medicine Policy 'Soon'

Gilead Sciences’ Kite subsidiary has won FDA approval for Yescarta™ (axicabtagene ciloleucel), the second time in less than two months that the agency has authorized a chimeric antigen receptor T-cell (CAR-T) treatment for a form of cancer.As with the first-approved CAR-T therapy , Novartis’ Kymriah (tisagenlecleucel), the FDA acted more than a month ahead of schedule. The agency had set a Prescription Drug User Fee Act (PDUFA) target decision date for Yescarta of November 29,