The U.S. Food and Drug Administration (FDA) has approved Gazyva® (Obinutuzumab) for adult patients with active lupus nephritis (LN) who are receiving standard therapy. The approval also allows a shorter infusion of approximately 90 minutes from the second dose onward for patients who tolerate the initial infusion without severe reactions.
Gazyva is a humanized monoclonal antibody that targets CD20 on B lymphocytes, promoting B-cell depletion through antibody-dependent cellular cytotoxicity, phagocytosis and direct cell death, with enhanced activity compared to Rituximab.
The dosing is as follows: In Cycle 1, patients receive a split-dose of 100 mg on Day 1 and 900 mg on Day 2, with infusion rates gradually increased based on tolerance. Days 8 and 15 consist of 1,000 mg infusions and for Cycles 2–6, patients receive 1,000 mg on Day 1 of each cycle. Missed doses should be administered as soon as possible, with adjustments made to maintain the dosing schedule.
Gazyva was previously approved for chronic lymphocytic leukemia (CLL) in combination with Chlorambucil and for follicular lymphoma (FL) in combination with Bendamustine or chemotherapy, followed by Gazyva monotherapy. This new indication extends its therapeutic reach from oncology to autoimmune nephrology, offering a biologic treatment option for a population with limited alternatives.
Lupus nephritis, a severe manifestation of systemic lupus erythematosus, causes inflammation and damage to kidney tissue, often leading to chronic renal complications.
The FDA’s decision provides a new targeted therapy that can help reduce disease activity and delay progression in patients who continue to experience renal inflammation despite standard treatment. This approval represents a significant advancement in lupus nephritis management, broadening clinicians’ therapeutic options and supporting further research into B-cell–directed immunomodulatory therapies for autoimmune kidney disease.
Disclaimer: This article is for informational purposes only and does not replace medical advice. Patients should consult their healthcare providers for guidance on diagnosis or treatment.
