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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Business News
April 17, 2026 15:29 ET The ongoing conflict in the Middle East continues to raise concerns for policymakers who worry about the impact of the supply shock and high energy prices on the real economy. Producer price data and various survey results on the housing market were the main news from the U.S. this week. In Europe, industrial production data for the euro area gained attention. GDP figures out of China and the policy move by the Singapore central bank were in focus in Asia.