Roche Advances Gazyva After Positive Phase III Data in Membranous Nephropathy

Roche will engage US and EU regulators after its Phase III MAJESTY trial (NCT04629248) showed that Gazyva (obinutuzumab) met its primary endpoint in membranous nephropathy. In the 104-week head-to-head study, Gazyva demonstrated a significantly higher complete remission rate than Prograf (tacrolimus), a commonly used off-label immunosuppressant from Astellas Pharma.

Key secondary endpoints also favored Gazyva, with statistically significant improvements in overall remission at week 104 and complete remission at week 76. The safety profile was consistent with prior studies, with no new signals identified.

If approved, Gazyva—marketed as Gazyvaro in the EU—could become the first authorised therapy for membranous nephropathy. Roche is also expanding development in related kidney and autoimmune diseases, while competitors including Biogen and BeOne Medicines pursue late-stage candidates.

26-02-2026