The FDA declined approval of Roche’s Columvi in combination therapy for second-line diffuse large B-cell lymphoma (DLBCL) patients ineligible for stem cell transplant, citing insufficient evidence from the phase 3 Starglo trial in U.S. populations. Despite positive data supporting the indication in Europe and the trial’s overall success, the FDA expressed concerns about regional survival imbalances. Roche plans to discuss alternate confirmatory studies with regulators. Columvi retains accelerated approval for third-line treatment.