Gazyva (obinutuzumab) for Primary membranous nephropathy
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The FDA is expected to decide on Gazyva for Primary membranous nephropathy 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
Read our full Membranous Nephropathy treatment summary
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.
The Membranous Nephropathy page has every treatment and trial →Meanwhile, 58 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:
Earlier-stage drugs Trial Friend tracks for Membranous Nephropathy
We'll email you when the decision is public, with what it means in plain language, and when new trials open for Membranous Nephropathy. Unsubscribe anytime.
Frequently asked questions
When will the FDA decide on Gazyva?
Genentech (Roche) expects a decision by November 2026 but has not given an exact date.
Who disclosed it: Genentech (Roche). The FDA does not publish these dates.
Can it move: the FDA can act early, and a major amendment to the application can push the date back 3 months.
Source: Genentech press release
What is Gazyva being reviewed for?
Genentech (Roche) submitted a sBLA for Gazyva in Primary membranous nephropathy.
What to know: 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.
Is there already an FDA-approved treatment for Membranous Nephropathy?
Trial Friend's drug list has no FDA-approved drug for Membranous Nephropathy yet.
Check: the Membranous Nephropathy page also searches FDA drug labels for approved treatments.
Can I get Gazyva before the FDA decides?
Usually only through a clinical trial or an expanded access program, and the company decides whether to offer one.
Trials: 58 Membranous Nephropathy trials are recruiting now. See them.
Check your fit: Match Me compares your details with every open trial.
Expanded access: your doctor can ask Genentech (Roche) directly. Registered programs are listed on ClinicalTrials.gov.
How much will Gazyva cost?
Genentech (Roche) has not announced a price. Drugmakers usually set it around approval.
Help paying: drugmaker programs and charity funds usually open at launch.
Find help: the patient assistance finder lists programs by insurance type.
What happens after the Gazyva decision?
This page updates with the outcome the day it is announced.
If approved: getting the drug still takes time. Specialty pharmacy setup, insurance review and patient assistance often take weeks. Our guide covers what families can do on day 1.
If not approved: a complete response letter means the FDA declined the application in its current form. Many are about manufacturing or how data were presented, and companies often resubmit.
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.