The FDA approved pivekimab sunirine-pvzy (Decnupaz) for adults with BPDCN on May 27, 2026, based on CADENZA trial data showing a 69.7% CR/CRc rate in treatment-naïve patients.
Roche announced positive Phase III MAJESTY trial results showing Gazyva achieved significantly higher complete remission rates at two years versus tacrolimus in primary membranous nephropathy, with no new safety signals identified.
Roche announced that Gazyva/Gazyvaro met its primary endpoint in the Phase III MAJESTY study for primary membranous nephropathy, showing statistically significant complete remission rates versus tacrolimus. The drug could become the first approved therapy for this rare autoimmune kidney disease.