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
June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.