Genentech : FDA Advisory Committee Reviews Columvi SBLA For DLBCL Treatment In Non-ASCT Candidates

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(RTTNews) - Genentech, a member of the Roche Group (RHHBY), announced that a U.S. Food and Drug Administration Oncologic Drugs Advisory Committee (ODAC) discussed the supplemental Biologics License Application or sBLA for Columvi (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of people with relapsed or refractory diffuse large B-cell lymphoma or DLBCL who are not candidates for autologous stem cell transplant or ASCT.

The ODAC provides the FDA with independent opinions and review of safety and efficacy data from outside medical experts, though the recommendations are not binding. The FDA's evaluation of this Columvi combination for relapsed or refractory diffuse large B-cell lymphoma is ongoing and a decision on approval is expected by July 20, 2025.

Today's discussion focused on the applicability of the Phase III STARGLO results to the U.S. patient population, with Committee members citing that further data are needed. The STARGLO study was a multiregional clinical trial (MRCT) that enrolled 274 patients globally across 62 sites in 13 countries, including the U.S., Australia, and multiple European countries, with the majority of patients (52%) enrolling outside of Asia.

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