Shots:
- The US FDA has granted Priority Review to the sBLA of Gazyva/Gazyvaro (obinutuzumab) in pMN, based on the P-III (MAJESTY) study assessing Gazyva vs tacrolimus in adults (n=142), with a decision expected by Nov 2026
- Trial met its 1EP, with 36.9% adults achieving CR at 2yrs. vs 5.7%, plus showed superiority across key 2EPs incl. overall remission (complete or partial remission) at Wk. 104 & complete remission at Wk. 76; data were published in The NEJM
- MAJESTY data are also submitted to global regulators, incl. the EMA, while Gazyva is also being evaluated in the P-II (POSTERITY) study for children & adolescents with lupus nephritis
Ref: Globenewswire | Image: Roche | Press Release
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