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News
The FDA has approved obinutuzumab (Gazyva) to reduce relapse risk in pediatric patients aged 2 and older with frequently relapsing or steroid-dependent idiopathic nephrotic syndrome. The decision is backed by the phase 3 INSHORE trial, which showed Gazyva significantly outperformed standard-of-care mycophenolate mofetil. The drug is now indicated for both adult and pediatric patients in remission.
The FDA has approved obinutuzumab (Gazyva, Genentech) for the treatment of idiopathic nephrotic syndrome (INS) in pediatric patients aged 2 years and older — a meaningful new option for a condition that can be notoriously difficult to manage in children. The drug is indicated to reduce the risk of relapse in patients with frequently relapsing or steroid-dependent, childhood-onset INS who are currently in remission.
The approval is anchored in data from the phase 3 INSHORE study, a randomized, controlled, open-label, multicenter trial that enrolled 85 patients aged 2 and older. Participants received either intravenous obinutuzumab (on days 1 and 15, and weeks 24 and 26) or twice-daily oral mycophenolate mofetil. The Gazyva group showed significantly greater achievement of the primary endpoint — a urine protein-creatinine ratio of ≤0.2 g/g at week 52 without relapse from weeks 8–52.
Key Takeaways:
Why it matters: Idiopathic nephrotic syndrome is one of the most common kidney diseases in children, and frequent relapses can lead to significant morbidity. This approval gives clinicians a new, evidence-backed tool to help keep young patients in remission.
