Biologics

Roche Files sBLA for Gazyva in Lupus

FDA has accepted for review a supplemental BLA for Gazyva (obinutuzumab) for treating lupus nephritis (LN). The agency has set a user fee review action target date of 10/2025.

The submission is based on data from the Phase 3 REGENCY trial. “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 certain patients with untreated chronic lymphocytic leukemia.

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FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome