FDA Accepts Genentech's Columvi Combo SBLA For R/R Diffuse Large B-Cell Lymphoma Treatment

(RTTNews) - Genentech, a member of the Roche Group (RHHBY), announced that the U.S. Food and Drug Administration has accepted the company's supplemental Biologics License Application (sBLA) for Columvi (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of people with relapsed or refractory (R/R) diffuse large B-cell lymphoma or DLBCL 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 application is based on data from the Phase III STARGLO study where Columvi plus chemotherapy showed a statistically significant and clinically meaningful improvement in overall survival.

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