FDA removes CNS limitation for Yescarta, reshaping the regulatory boundary for CAR T therapy in primary CNS lymphoma

FDA removes CNS limitation for Yescarta, reshaping the regulatory boundary for CAR T therapy in primary CNS lymphoma

Kite Pharma, a subsidiary of Gilead Sciences, has received approval from the U.S. Food and Drug Administration to update the prescribing information for Yescarta axicabtagene ciloleucel by removing the prior limitation of use in patients with relapsed or refractory primary central nervous system lymphoma. The decision follows safety findings from an investigator sponsored Phase 1 […]