5 December 2024 - Application is based on data from the Phase 3 STARGLO study where Columvi plus chemotherapy showed a statistically significant and clinically meaningful improvement in overall survival.
Roche announced today that the US FDA has accepted the company’s supplemental biologics license application for Columvi (glofitamab) in combination with gemcitabine and oxaliplatin for the treatment of people with relapsed or refractory diffuse large B-cell lymphoma who have received at least one prior line of therapy and are not candidates for autologous stem cell transplant.