Story perspectives

FDA Approves Gazyva as Breakthrough Lupus Nephritis Treatment

10/22/2025

31 2

Summary

Story summary

The FDA approved Gazyva (obinutuzumab) as add-on therapy for adults with lupus nephritis, marking the first anti-CD20 monoclonal antibody approved for this condition.
The approval rests on Phase 2 NOBILITY and Phase 3 REGENCY results, with 46.4% complete kidney responses on Gazyva versus 33.1% with standard therapy.
Gazyva is given by infusion with a streamlined dosing schedule to improve patient adherence.
Common side effects include infections and infusion-related reactions.

1 of 1

Story summary

The FDA approved Gazyva (obinutuzumab) as add-on therapy for adults with lupus nephritis, marking the first anti-CD20 monoclonal antibody approved for this condition.
The approval rests on Phase 2 NOBILITY and Phase 3 REGENCY results, with 46.4% complete kidney responses on Gazyva versus 33.1% with standard therapy.
Gazyva is given by infusion with a streamlined dosing schedule to improve patient adherence.
Common side effects include infections and infusion-related reactions.