Phase III Trial
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Gazyva/Gazyvaro Shows Positive Phase III Results in Pediatric and Young Adult Idiopathic Nephrotic Syndrome
Roche’s Phase III INShore study of Gazyva/Gazyvaro in children (2-25 years) with idiopathic nephrotic syndrome (INS) met its primary endpoint, showing a statistically significant increase in sustained complete remission at week 52 compared to mycophenolate mofetil (MMF). The study also demonstrated improvements in relapse-free survival and reduced corticosteroid use. The safety profile was consistent with that in adults. Roche plans to present the data to regulatory agencies, including the FDA and EMA.
