
FDA Approves Gazyva for Active Lupus Nephritis
Key Takeaways
- Obinutuzumab is the first anti-CD20 monoclonal antibody approved for active lupus nephritis, addressing a significant unmet clinical need.
- The REGENCY and NOBILITY trials demonstrated superior renal outcomes with obinutuzumab plus standard therapy compared to standard therapy alone.
The FDA approves obinutuzumab (Gazyva; Genentech, Roche) for lupus nephritis, offering a new treatment option with improved renal outcomes for patients.
The FDA approved obinutuzumab (Gazyva; Genentech, Roche) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy, marking the first anti-CD20 monoclonal antibody approved for this indication.1,2 This decision represents a significant milestone in lupus care, addressing an area of high unmet clinical need and expanding the therapeutic landscape for patients with systemic lupus erythematosus (SLE)–related kidney disease.
The FDA’s decision was supported by data from the pivotal phase III REGENCY trial (NCT04221477)3 and the phase II NOBILITY trial (NCT02550652)4, which together demonstrated superior renal outcomes with obinutuzumab plus standard therapy compared with standard therapy alone.1,3
In REGENCY, 271 patients with biopsy-proven proliferative LN were randomized 1:1 to receive either obinutuzumab or placebo alongside standard of care. At week 76, 46.4% of patients treated with obinutuzumab achieved a complete renal response (CRR) compared with 33.1% in the placebo group (adjusted difference, 13.4 percentage points; 95% CI, 2.0 to 24.8; P = .02).3 Secondary end points also favored obinutuzumab, including CRR with a prednisone dose less than or equal to 7.5 mg/day (42.7% vs 30.9%) and a urinary protein-to-creatinine ratio less than 0.8 without rescue therapy (55.5% vs 41.9%).3
“Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomized phase III study,” Roche stated in its press release.2 This improvement is particularly significant given the historical challenges of achieving complete renal remission in LN with current immunosuppressive regimens.
Gazyva is indicated for adults with active LN receiving standard therapy and offers a more convenient administration schedule than many existing options.2 The recommended regimen includes four initial doses in the first year, followed by infusions administered twice annually thereafter. Additionally, the label allows eligible patients to receive subsequent infusions over 90 minutes following the first dose, improving infusion-center efficiency and patient convenience.2
This streamlined dosing is an important consideration for pharmacists and infusion centers, which often face logistical challenges with biologic therapies. Reduced chair time and predictable dosing intervals may improve adherence and reduce overall treatment burden for patients.
“People with lupus nephritis face a significant risk of kidney failure, and many still fail to respond adequately to existing treatment options,” said Levi Garraway, MD, PhD, chief medical officer and head of global product development at Roche.2 “Gazyva’s approval provides a much-needed new option for these patients.”
The safety profile of obinutuzumab in LN was consistent with its known safety in oncology indications. The most common serious adverse events were infections, including COVID-19-related events, though no new safety signals were identified.3 Obinutuzumab is a humanized type II anti-CD20 monoclonal antibody that depletes B cells, thereby reducing autoimmune-driven inflammation and kidney damage.3
For pharmacists, careful patient monitoring is essential. Infusion-related reactions, infection risk, and B-cell depletion should be managed proactively, and coordination with the care team is critical for optimal outcomes. Patient education is also key; explaining the mechanism of action and expected outcomes can support adherence and set realistic expectations.
The approval of Gazyva introduces a powerful new option for patients with LN and will likely shift treatment paradigms in rheumatology and nephrology. Pharmacists will play a central role in integrating obinutuzumab into care, including verifying compatibility with standard regimens such as mycophenolate mofetil and corticosteroids, monitoring for adverse effects, and educating patients on therapy goals.3 Additionally, infusion center teams must prepare for new scheduling and monitoring requirements associated with the biannual dosing schedule.
REFERENCES
Genentech: Press Releases | Sunday, Oct 19, 2025. Gene.com. Published 2025. Accessed October 20, 2025.
https://www.gene.com/media/press-releases/15085/2025-10-19/fda-approves-genentechs-gazyva-for-the-t FDA approves Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis. Roche.com. Published 2025. Accessed October 20, 2025.
https://www.roche.com/media/releases/med-cor-2025-10-20 Furie RA, Rovin BH, Garg JP, et al. Efficacy and Safety of Obinutuzumab in Active Lupus Nephritis. N Engl J Med. 2025;392(15):1471-1483. doi:10.1056/NEJMoa2410965
Furie RA, Aroca G, Cascino MD, et al. B-cell depletion with obinutuzumab for the treatment of proliferative lupus nephritis: a randomized, double-blind, placebo-controlled trial. Ann Rheum Dis. 2022;81(1):100-107. doi:10.1136/annrheumdis-2021-220920
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