FDA Rejects Roche's Bid for Columvi Combo in Early-Line DLBCL

Roche faced a regulatory setback today as the U.S. FDA issued a Complete Response Letter (CRL) for its bid to expand Columvi (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) for certain DLBCL patients.

The rejection targets use in relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) patients ineligible for stem cell transplant. The FDA cited concerns over limited U.S. representation in the STARGLO trial, with only about 9% of participants enrolled domestically.

The submission was based on results from the Phase III STARGLO trial, which showed the Columvi combination reduced the risk of death by 41% and improved progression-free survival by 63% compared to the standard rituximab-GemOx regimen. Despite these promising outcomes, the FDA concluded the data lacked sufficient representation of U.S. patients, with only around 9% of enrollees from the U.S. and nearly half from Asia.

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This led to an FDA advisory panel vote of 8–1 against approval, citing concerns about the applicability of results to the U.S. population. The rejection halts Roche’s attempt to move Columvi into earlier lines of treatment, though it remains approved for third-line use under accelerated approval.

Roche is currently in dialogue with the agency and plans to pursue further development through ongoing trials like SKYGLO, aimed at frontline DLBCL. While this decision delays expansion, Columvi’s strong clinical profile keeps it central in Roche’s oncology strategy.