Gazyva (obinutuzumab) for Primary membranous nephropathy
The FDA is expected to decide on Gazyva for Primary membranous nephropathy in By November 2026, under a sBLA from Genentech (Roche).
What is being decided
Genentech (Roche) has a sBLA under FDA review for Gazyva (obinutuzumab) in Primary membranous nephropathy. Priority review and Breakthrough Therapy designation. Would be the first FDA-approved treatment for primary membranous nephropathy. In the Phase 3 MAJESTY trial, 36.9% of adults on Gazyva reached complete remission at two years versus 5.7% on tacrolimus. Genentech has said only that it expects an FDA decision by November 2026. Gazyva, a B cell-depleting antibody, is already approved for lupus nephritis and, since September 25, 2026, for idiopathic nephrotic syndrome.
Who this decision matters to
Membranous nephropathy is a rare autoimmune kidney disease where the body's own antibodies attack proteins in the kidney's filtering units (glomeruli). This causes thickening of the filter membranes and leakage of protein into the urine, leading to nephrotic syndrome. In about 70-80% of primary cases, the target is a protein called PLA2R on the surface of kidney cells.
Prevalence: About 12 new cases per million people each year in the U.S.; roughly 40,000-50,000 Americans living with the disease. See our full Membranous Nephropathy page for current treatments, recruiting trials, and community resources.
What each outcome would mean
An approval starts a second race rather than ending the first one: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. Our guide to the 90 days after a rare disease approval explains the timeline and the moves families can make on day 1.
A complete response letter would mean the FDA declined to approve in the application's current form. CRLs are often about manufacturing or data presentation rather than efficacy, and resubmission is common. Either way, this page updates with the outcome and what it means.
Where Membranous Nephropathy treatment stands today
Membranous nephropathy care is shifting from broad immunosuppression toward precision approaches that target the specific autoantibodies driving the disease. Clinical trials are testing next-generation B-cell-depleting antibodies, complement inhibitors, and investigational autoantibody degraders like Biohaven's BHV-1420, which is designed to selectively remove anti-PLA2R IgG while leaving the rest of the immune system intact. If you have anti-PLA2R-positive membranous nephropathy with persistent proteinuria above 4 g/day despite supportive care, you may qualify for trials of these targeted therapies. The NephCure Kidney International website and the National Kidney Foundation maintain current trial information. Because anti-PLA2R antibody levels track closely with disease activity, newer trials often use serologic response as an early efficacy signal, which can speed the path to approval.
Meanwhile, 69 Membranous Nephropathy trials are recruiting
Whatever the FDA decides here, research on Membranous Nephropathy does not stop. A few currently enrolling studies, US sites first:
Other drugs Trial Friend tracks for Membranous Nephropathy
Get notified when new membranous-nephropathy trials open or existing trials change status, add sites, or update eligibility.
Frequently asked questions
When will the FDA decide on Gazyva?
Genentech (Roche) has disclosed a decision window of By November 2026 for Gazyva in Primary membranous nephropathy, without an exact date.
What is Gazyva being reviewed for?
Genentech (Roche) submitted a sBLA for Gazyva in Primary membranous nephropathy. Priority review and Breakthrough Therapy designation. Would be the first FDA-approved treatment for primary membranous nephropathy. In the Phase 3 MAJESTY trial, 36.9% of adults on Gazyva reached complete remission at two years versus 5.7% on tacrolimus. Genentech has said only that it expects an FDA decision by November 2026. Gazyva, a B cell-depleting antibody, is already approved for lupus nephritis and, since September 25, 2026, for idiopathic nephrotic syndrome.
What happens after the Gazyva decision?
If approved, availability is not immediate: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. If the FDA issues a complete response letter, the application was not approved in its current form; CRLs are often about manufacturing or data presentation rather than efficacy, and sponsors frequently resubmit. This page updates with the outcome either way.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from Genentech press release. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified daily.