Key Takeaways:
- FDA granted Priority Review to Roche's Gazyva for primary membranous nephropathy
- Phase III MAJESTY showed 36.9% complete remission vs 5.7% for tacrolimus
- PDUFA decision expected by November 2026; no approved therapies exist for pMN
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Roche wins FDA Priority Review for Gazyva in kidney disease
The US Food and Drug Administration granted Priority Review to Roche's Gazyva (obinutuzumab) for adults with primary membranous nephropathy, a chronic autoimmune kidney disease with no approved therapies in the US or Europe. A decision is expected by November 2026.
"The results from the MAJESTY study showed that Gazyva achieved a complete remission rate of 36.9 percent at two years, compared with 5.7 percent for tacrolimus," Levi Garraway, chief medical officer and global product development head at Roche, said. "By targeting tissue-resident B cells, Gazyva addresses an underlying cause of pMN and has the potential to help patients maintain kidney function."
The Phase III MAJESTY trial enrolled adults with pMN and met its primary endpoint with an adjusted difference of 31.1 percent favoring Gazyva over the immunosuppressive therapy. Secondary endpoints showed benefits in overall remission and remission at week 76. Safety findings aligned with the known profile for Gazyva, with no new signals observed. The data were presented at the 63rd European Renal Association Congress in June and published in the New England Journal of Medicine.
Up to 30 percent of untreated pMN patients progress to kidney failure within 10 years, according to estimates cited by Roche. The FDA had previously granted Breakthrough Therapy Designation for Gazyva in pMN in April 2026. This marks the second Priority Review for the drug this year, following its acceptance for idiopathic nephrotic syndrome in May. Gazyva is already approved in the US and EU for lupus nephritis and in more than 100 countries for hematological malignancies.
Gazyva generated $247 million in first-quarter sales, up 10 percent year over year. The MAJESTY study is the fourth positive Phase III trial for Gazyva in immune-mediated diseases, following the REGENCY study in lupus nephritis, ALLEGORY in systemic lupus erythematosus and INShore in idiopathic nephrotic syndrome. Roche is also evaluating the drug in the Phase II POSTERITY study for children and adolescents with lupus nephritis.
An approval would make Gazyva the first FDA-approved therapy for pMN, expanding Roche's nephrology franchise and strengthening its immunology pipeline. Beyond Gazyva, Roche is advancing Lunsumio (mosunetuzumab), a CD20xCD3 T-cell-engaging bispecific antibody, in systemic lupus erythematosus. Investors will watch for the PDUFA decision in November 2026 and for continued regulatory filings with global health authorities including the European Medicines Agency.
This article is for informational purposes only and does not constitute investment advice.
