The U.S. Food and Drug Administration approved obinutuzumab (Gazyva/Gazyvaro) for adult patients with active lupus nephritis receiving standard therapy, based on phase II NOBILITY and phase III REGENCY results showing higher complete renal response versus standard therapy alone.
 
In REGENCY, 46.4% of patients receiving obinutuzumab plus standard therapy achieved complete renal response compared with 33.1% on standard therapy alone; treatment also improved complement levels, reduced anti–double-stranded DNA antibodies, lowered proteinuria, and enabled corticosteroid reductions. The safety profile was consistent with that observed in hematologic indications.
 
Up to one-third of patients with lupus nephritis progress to end-stage kidney disease if untreated. Obinutuzumab, a type II humanized anti-CD20 monoclonal antibody, selectively targets B cells that drive renal inflammation.
 
The regimen allows four initial infusions in the first year followed by twice-yearly maintenance; eligible patients may receive a shortened 90-minute infusion after the first administration.
 
Regulatory notes: In 2019, the U.S. Food and Drug Administration granted Breakthrough Therapy Designation for lupus nephritis based on NOBILITY, and the European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion recommending approval, with a final decision pending.

Source: Roche