FDA Rejects Roche's Columvi for Earlier DLBCL Treatment, Citing Insufficient U.S. Data

The U.S. Food and Drug Administration (FDA) has declined to approve Roche's Columvi for the treatment of second-line diffuse large B-cell lymphoma (DLBCL) patients who are not eligible for autologous stem cell transplant. The decision, announced by Roche and its subsidiary Genentech on July 18, 2025, comes as a setback for the pharmaceutical giant's efforts to expand the use of Columvi in earlier treatment settings.

FDA Concerns Over U.S. Patient Representation

In a complete response letter, the FDA cited concerns that the phase 3 Starglo trial data do not provide sufficient evidence to support the proposed indication in a U.S. population. The rejection aligns with the recent FDA advisory committee meeting outcome, where external experts voted 8 to 1 against the applicability of Starglo results to U.S. patients.

The FDA's decision highlights a growing emphasis on increasing U.S. representation in oncology clinical trials. Richard Pazdur, M.D., the FDA's oncology leader, recently stated, "Unfortunately, if you take a look at all the oncology trials that come to us, only about 20% of the population is derived from the United States. We'd like to see robust increased enrollment in the United States."

Implications for Columvi and Future Studies

Despite the setback in expanding Columvi's use, Roche remains confident in the drug's value for U.S. patients who have relapsed following initial treatment. Levi Garraway, M.D., Ph.D., Roche's chief medical officer and head of global product development, stated, "While we are disappointed with this outcome, we remain confident in the data supporting the value of Columvi for U.S. patients who have relapsed following initial treatment, and its key role as monotherapy in the third-line setting."

Roche is now in discussions with the FDA to potentially use the phase 3 Skyglo study as a confirmatory trial for Columvi's accelerated approval in the third-line setting. The Skyglo study is testing Columvi in combination with Roche's Polivy-R-CHP regimen in patients with previously untreated CD20-positive large B-cell lymphoma.