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The FDA is expected to decide on Gazyva for Primary membranous nephropathy by November 2026, under an sBLA from Genentech (Roche).
What the FDA is deciding on Gazyva for Primary membranous nephropathy
The FDA is reviewing Genentech (Roche)'s request to approve Gazyva (obinutuzumab) for a new use, 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 2 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 the Gazyva 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.
How Gazyva works
Gazyva: anti-CD20 antibody that removes B cells. Our full Gazyva profile covers how it works, side effects in plain language, and its trial history.
What an approval or a rejection of Gazyva 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. The letter describes what the FDA wants addressed, and the company then decides whether to resubmit, run more studies or stop. 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 4g/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. Genentech's Gazyva (obinutuzumab) is under FDA priority review for adults with primary membranous nephropathy, with a decision expected by November 2026.
In the Phase 3 MAJESTY trial, 36.9% of adults on Gazyva reached complete remission at 2 years versus 5.7% on tacrolimus.
Of the 4 Phase 3 membranous nephropathy trials enrolling in the US, 3 compare their drug with tacrolimus: Biogen's felzartamab (NCT06962800), Amgen's inebilizumab (NCT07851220) and Vertex's povetacicept (NCT07204275). The fourth tests Cerium's SNP-ACTH gel against rituximab (NCT05696613), per Trial Friend's reading of each ClinicalTrials.gov record on October 23, 2026.
If you join a trial with a tacrolimus arm, ask what rescue treatment is offered and whether the plan changes if Gazyva is approved.
The Membranous Nephropathy page has every treatment and trial →Meanwhile, 63 Membranous Nephropathy studies are recruiting or not yet recruiting
Whatever the FDA decides here, research on Membranous Nephropathy does not stop. The most recently updated:
Earlier-stage drugs Trial Friend tracks for Membranous Nephropathy
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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 an 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 2 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.
How it works: Anti-CD20 antibody that removes B cells.
More: the Gazyva drug page explains it in plain language.
Is there already an FDA-approved treatment for Membranous Nephropathy?
No. No medicine's current FDA label names Membranous Nephropathy, checked October 21, 2026.
Check: the Membranous Nephropathy page also searches FDA drug labels for approved treatments.
What did the Gazyva trials show?
In MAJESTY (NCT04629248), 142 adults with primary membranous nephropathy got 4 Gazyva infusions or tacrolimus pills; at 2 years, 37% on Gazyva were in complete remission against 6% on tacrolimus (NEJM 2026). The FDA is reviewing that use, with a decision expected by November 2026.
More: the Gazyva drug page has the full trial history and sources.
What are the side effects of Gazyva?
Gazyva has a boxed warning for hepatitis B coming back and for PML, a rare, serious brain infection. In the pooled lupus nephritis trials, the most common side effects against placebo were upper respiratory infections (29% against 24%), COVID-19 (23% against 16%), urinary tract infections (21% against 18%), bronchitis (14% against 8%), infusion reactions (14% against 10%), low white blood cell counts (14% against 6%) and pneumonia (10% against 6%).
More: the Gazyva drug page has the label's warnings in full.
Can I get Gazyva before the FDA decides?
Gazyva is already FDA approved for other conditions, but not yet for Primary membranous nephropathy, and insurers may not cover use for an unapproved condition.
Trials: 63 Membranous Nephropathy studies are recruiting or not yet recruiting. 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?
Gazyva is already sold in the US for other conditions. Trial Friend does not list a price, and coverage for Primary membranous nephropathy depends on the FDA decision and your insurer.
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.