FDA Advisory Committee Splits Votes on Genentech and J&J Cancer Drugs

On May 20, 2025, the FDA's Oncologic Drugs Advisory Committee (ODAC) held a meeting to assess applications from Genentech and Johnson & Johnson (J&J) for new indications of cancer drugs targeting relapsed/refractory diffuse large B-cell lymphoma (DLBCL)15.

The committee voted 8 to 1 against the applicability of Genentech's pivotal clinical trial data to U.S. patients for Columvi (glofitamab), expressing concerns that the trial population did not sufficiently represent U.S. patients235.

The vote reflected skepticism about whether results from the international STARGLO trial could be generalized to the U.S. population, which may impact the likelihood of FDA approval for Columvi in this new indication35.

There were split or differing votes regarding J&J's (Johnson & Johnson) cancer drug applications (specific outcome details were not provided in the immediate results, but coverage indicates disagreement among committee members)5.

FDA leaders, following the advisory committee meeting, emphasized the need for more U.S.-based enrollment in cancer drug trials to improve data relevance for future approvals2.

Sources:

1. https://www.gene.com/media/press-releases/15061/2025-05-20/genentech-provides-update-on-fda-advisor

2. https://www.fiercepharma.com/pharma/roches-columvi-expansion-bid-danger-fdas-makary-pazdur-push-changes

3. https://www.onclive.com/view/fda-odac-votes-against-the-applicability-of-starglo-data-for-glofitamab-plus-chemo-for-u-s-patients-with-r-r-dlbcl

5. https://endpts.com/fda-adcomm-votes-against-new-indication-for-genentechs-cancer-drug/