Roche and subsidiary Genentech received a complete response letter from the FDA declining approval to expand Columvi’s indication to earlier treatment for diffuse large B-cell lymphoma (DLBCL) patients ineligible for stem cell transplant. The FDA cited insufficient evidence from the phase 3 Starglo trial in the U.S. population despite positive outcomes in Europe. Roche is exploring alternative confirmatory studies such as Skyglo to satisfy accelerated approval requirements. Columvi remains available under accelerated approval for third-line therapy. The FDA’s caution centers on survival imbalances across geographic subgroups.