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# Roche Shares Positive Data on Gazyva
- URL: https://www.fdaweb.com/roche-shares-positive-data-on-gazyva/
- Published: 2025-02-07T12:00:00.000Z
- Updated: 2026-09-14T14:52:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158621

Roche says it is sharing with FDA positive data from the Phase 3 REGENCY trial of Gazyva (obinutuzumab) in people with active lupus nephritis (LN). “The study demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of complete renal response (CRR), showing that 46.4% of people treated with Gazyva/Gazyvaro plus standard therapy (mycophenolate mofetil and glucocorticoids) achieved CRR at 76 weeks compared with 33.1% of people treated with standard therapy alone,” the company says. “This was accompanied by clinically meaningful improvements in complement levels and reductions in anti-dsDNA, markers of disease activity and inflammation.”

Gazyva’s safety profile was consistent with the well-characterized profile observed in its hematology/oncology indications, Roche says. “Key secondary endpoints showed that at week 76, patients who received Gazyva plus standard therapy were more likely to achieve CRR, with a successful reduction of corticosteroid use than standard therapy alone,” it says. Despite current treatment options, up to a third of people with LN develop end-stage kidney disease within 10 years, where dialysis or transplant are usually the only options and mortality risk becomes high, Roche says.

Gazyva is described as the only anti-CD20 monoclonal antibody to demonstrate a CRR benefit in a randomized phase 3 study in lupus nephritis. It is currently approved for treating lymphoma and and certain patients with untreated chronic lymphocytic leukemia.