Roche reported that the FDA declined approval for Columvi (a CD20xCD3 T-cell engager) in combination with chemotherapy for patients with diffuse large B-cell lymphoma (DLBCL) ineligible for stem cell transplant, based on incomplete applicability of the Starglo phase 3 trial data to the U.S. population. Despite positive results leading to European approval, the FDA’s complete response letter cites regional survival imbalances. Roche is discussing alternate confirmatory trials, including Skyglo, to support further regulatory submissions. The drug maintains accelerated approval in third-line DLBCL.