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
When will the FDA decide on Gazyva?
The FDA has already decided: the application was approved. See the outcome details above.
What is Gazyva being reviewed for?
Genentech (Roche) submitted a sBLA for Gazyva 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.
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 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.