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 […]

What Arcus Biosciences’ STAR-221 failure reveals about TIGIT fatigue in immunotherapy

What Arcus Biosciences’ STAR-221 failure reveals about TIGIT fatigue in immunotherapy

Arcus Biosciences, Inc. has terminated its global Phase 3 STAR-221 study evaluating domvanalimab, an investigational anti-TIGIT antibody, in combination with zimberelimab and chemotherapy for advanced upper gastrointestinal cancers. The discontinuation, announced in partnership with Gilead Sciences, Inc., followed a pre-specified interim overall survival analysis that found no benefit compared to the nivolumab-based control arm. Arcus […]