FDA approves efficacy supplement for Genentech's Gazyva

The U.S. Food and Drug Administration approved a supplemental application for Gazyva (obinutuzumab), according to an FDA record dated September 25, 2026. The submission is listed as supplement number 43 under application BLA125486, sponsored by Genentech, with a submission status of "AP," meaning approved.¹

The FDA classified the submission as an efficacy supplement and gave it priority review.¹

Gazyva is an injectable formulation of obinutuzumab. The product record lists it as an injection with a dosage form described as injectable and an active ingredient strength of 1000 mg per 40 mL.¹

The FDA's disclosure does not specify what change the supplement covers, such as a new indication, dosing regimen, or label update. No additional details on the clinical basis for the approval, trial data, or the specific label changes were included in the available record. Readers seeking the underlying rationale would need to consult Genentech's own announcements or the FDA's approval letter and label, neither of which is part of this record.

No further milestones or next steps were listed in the FDA database entry as of the September 25, 2026 status date.