The US Food and Drug Administration (FDA) has approved Gazyva®/Gazyvaro® (obinutuzumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy, an announcement made by Roche that marks a significant advancement for a condition affecting over $1.7$ million people worldwide, predominantly women of color and childbearing age, which can lead to end-stage kidney disease.

This approval is based on the superiority demonstrated over standard therapy alone in the phase II NOBILITY and pivotal phase III REGENCY studies, establishing Gazyva/Gazyvaro as the only anti-CD20 monoclonal antibody to show a complete renal response (CRR) benefit in a randomized phase III trial for this indication. Specifically, the REGENCY data showed that nearly half of participants (46.4%) on Gazyva/Gazyvaro plus standard therapy achieved a CRR, compared to 33.1% on standard therapy alone, with a CRR being clinically linked to preserved kidney function and delayed progression to kidney failure.

The treatment offers a potentially more convenient regimen, with four initial doses in the first year followed by administration only twice yearly, along with a shorter 90-minute infusion time for eligible patients after the first dose. By depleting the disease-causing B cells that drive inflammation and damage the kidneys, Gazyva/Gazyvaro offers new hope for more effective disease control, potentially preventing the severe, long-term complications associated with this life-threatening autoimmune manifestation.