Roche announced that the US Food and Drug Administration (FDA) has accepted the company?s supplemental Biologics License Application (sBLA) for Gazyva/Gazyvaro (obinutuzumab) for the treatment of systemic lupus erythematosus (SLE). The filing acceptance is based on positive results from the phase III ALLEGORY study, which demonstrated a statistically significant and clinically meaningful benefit in the primary endpoint of SLE Responder Index 4 (SRI-4) at 52 weeks ? a measure that assesses changes in disease severity, symptoms and physical condition.
The FDA is expected to make a decision on an approval by December 2026. Gazyva/Gazyvaro is already approved for adults with lupus nephritis in the US and EU. These data were simultaneously presented at the 15th European Lupus meeting, SLEuro 2026 and published in the New England Journal of Medicine in March 2026.
The phase III ALLEGORY results showed over three quarters (76.7%) of people treated with Gazyva/Gazyvaro plus standard therapy achieved a minimum four-point improvement in SRI-4 at 52 weeks, compared to 53.5% with placebo plus standard therapy (adjusted difference 23.1%, 95% confidence interval [CI]: 12.5-33.6, p Gazyva/Gazyvaro (obinutuzumab) is a humanised monoclonal antibody designed with a Type II anti-CD20 region, for direct B cell death, and a glycoengineered Fc region, for higher binding affinity and increased antibody-dependent cellular cytotoxicity (ADCC). CD20 is a protein found on certain types of B cells. Gazyva/Gazyvaro is also approved in 100 countries for various types of haematological cancers.
ALLEGORY [NCT04963296] is a phase III, randomised, double-blind, placebo-controlled, multicentre study, investigating the efficacy and safety of Gazyva/Gazyvaro (obinutuzumab) compared with placebo in adults with systemic lupus erythematosus (SLE) on standard therapy. The study enrolled approximately 300 people, who were randomised 1:1 to receive Gazyva/Gazyvaro or placebo for up to one year (52 weeks), followed by an open-label period with Gazyva/Gazyvaro for up to 104 weeks. The primary endpoint is the percentage of people who achieve SLE Responder Index four at week 52.
Systemic lupus erythematosus (SLE) is a potentially life-threatening autoimmune disease that affects more than three million people worldwide, and is rising. It is a chronic disease that causes inflammation in various parts of the body; for this reason, it can affect multiple organ systems, especially the skin, joints and kidneys. As multiple organ systems are affected, it can cause varying symptoms, often taking two to six years for an accurate diagnosis.
During this time, disease severity and organ damage, due to repeated flares of disease activity, typically worsens and quality of life declines. Around half of people with SLE will develop lupus nephritis within five years of a lupus diagnosis. In lupus nephritis, the disease activity primarily affects the kidneys, posing a risk of kidney failure, where dialysis and transplant are the only treatment options.
There is a need for additional targeted therapies that can effectively control SLE disease activity and potentially delay or prevent the onset of lupus nephritis.
