Gazyva (obinutuzumab) for Idiopathic nephrotic syndrome
What the FDA decided
The FDA approved Genentech (Roche)'s sBLA for Gazyva (obinutuzumab) in Idiopathic nephrotic syndrome. Approved September 25, 2026 to reduce the risk of relapse in adults and children 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. Idiopathic nephrotic syndrome is the most common cause of nephrotic syndrome in children, usually starting between ages 2 and 7. In the 85-patient Phase 3 INShore trial (NCT05627557), significantly more patients on Gazyva stayed relapse-free with normal urine protein at week 52 than on mycophenolate mofetil, a common standard treatment. Gazyva was already approved for certain blood cancers and for lupus nephritis. The label carries a boxed warning for hepatitis B reactivation and progressive multifocal leukoencephalopathy, a rare brain infection; the most common side effects in this use were infections, infusion reactions and low neutrophil counts. It held Breakthrough Therapy, Orphan Drug and Priority Review designations.
Frequently asked questions
Has the FDA decided on Gazyva?
The FDA has already decided. It approved the application.
Details: the outcome and what it means are at the top of this page.
Source: FDA approval notice
What was Gazyva approved for?
The FDA approved Genentech (Roche)'s sBLA for Gazyva in Idiopathic nephrotic syndrome.
What to know: Approved September 25, 2026 to reduce the risk of relapse in adults and children 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. Idiopathic nephrotic syndrome is the most common cause of nephrotic syndrome in children, usually starting between ages 2 and 7. In the 85-patient Phase 3 INShore trial (NCT05627557), significantly more patients on Gazyva stayed relapse-free with normal urine protein at week 52 than on mycophenolate mofetil, a common standard treatment. Gazyva was already approved for certain blood cancers and for lupus nephritis. The label carries a boxed warning for hepatitis B reactivation and progressive multifocal leukoencephalopathy, a rare brain infection; the most common side effects in this use were infections, infusion reactions and low neutrophil counts. It held Breakthrough Therapy, Orphan Drug and Priority Review designations.
How much will Gazyva cost?
Trial Friend does not list a price for Gazyva. What you pay depends on your insurance and on help from the drugmaker or a charity fund.
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 FDA approval notice. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified daily.