Gazyva (obinutuzumab) - (MAJESTY)

July 14, 2026: Genentech (Roche Group; SIX: RO, ROP; OTCQX: RHHBY) said the FDA granted Priority Review to its supplemental BLA for Gazyva (obinutuzumab) to treat primary membranous nephropathy (pMN) in adults. The FDA is expected to decide by November 2026; Gazyva previously received Breakthrough Therapy Designation for pMN in April 2026. The company noted this is the second recent Priority Review for Gazyva, following idiopathic nephrotic syndrome in May 2026.

The filing is supported by the Phase III MAJESTY trial (NCT04629248; n=142; randomized 1:1, open-label), which met its primary endpoint: complete remission at 2 years (week 104) was 36.9% with Gazyva vs 5.7% with tacrolimus (adjusted difference 31.1%; 95% CI 18.2–44.0; p<0.001). Key secondary endpoints also favored Gazyva for overall remission at week 104 and complete remission at week 76; safety was consistent with the known profile with no new signals.

MAJESTY data were presented as a late-breaking oral at the 63rd ERA Congress (June 2026) and published in NEJM; submissions to other regulators including the EMA are planned/ongoing.