FDA grants priority review to Roche's Gazyva in primary membranous nephropathy

15. Jul 2026

Description

(AWP Alliance News) - Roche's Genentech won FDA priority review for a supplemental biologics application seeking to expand Gazyva to treat adults with primary membranous nephropathy. The agency is expected to decide on approval by November 2026. The filing is backed by Phase III MAJESTY data showing 36.9% complete remission at 104 weeks with Gazyva versus 5.7% with tacrolimus.

https://www.businesswire.com/news/home/20260714394570/en/

Disclaimer: This news brief was created using generative artificial intelligence. Roche Holding AG published the original content used to generate this news brief via Business Wire on July 15, 2026, and is solely responsible for the information contained therein.