Genentech announces FDA acceptance of Columvi combination sBLA

Genentech, a member of Roche (RHHBY), announced that the FDA has accepted the company’s supplemental biologics license application, or sBLA, for Columvi 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. The FDA is expected to make a decision on approval by July 20, 2025. The standard second-line therapy for R/R DLBCL patients has historically been high-dose chemotherapy followed by stem-cell transplant, however, not all patients are a candidate due to age or coexisting medical conditions.