Roche (SIX: RO, ROP; OTCQX: RHHBY) 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.2 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.
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“The FDA’s sBLA acceptance for Gazyva/Gazyvaro brings us one step closer to providing a highly effective new treatment option for people living with this unpredictable and potentially life-threatening disease,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “Gazyva/Gazyvaro may offer meaningful improvements in disease control and increase the likelihood of achieving complete remission in SLE while reducing the burden of long-term steroid use.”
“For people living with SLE, the daily challenges of the disease can be both physically and emotionally overwhelming,” said Albert T. Roy, President and CEO, Lupus Research Alliance. “We are hopeful for the approval of Gazyva as a new treatment for SLE given its potential to manage symptoms as well as drive higher rates of clinical remission and reduce the frequency of debilitating flares.’’
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.
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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<0.001). Safety was consistent with the well-characterised profile of Gazyva/Gazyvaro, and no new safety signals were identified.
Gazyva/Gazyvaro was also superior to placebo in all key secondary endpoints, and met additional secondary endpoints, including the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response at 52 weeks and glucocorticoid reduction to ≤7.5 mg/day, sustained from week 40 to 52. The study showed that people receiving Gazyva/Gazyvaro, plus standard therapy, were less likely to have a flare through to week 52, as defined by the British Isles Lupus Assessment Group (BILAG) index (Hazard ratio [HR]: 0.58, 95% CI: 0.40-0.82, p=0.002). A relevant finding as flares can lead to permanent organ damage. The median time to first flare could not be estimated. In addition, treatment with Gazyva/Gazyvaro plus standard therapy, versus placebo plus standard therapy, more than doubled the remission rate at 52 weeks (Definition of Remission in SLE (DORIS) – 33.8% versus 13.8%, adjusted difference 19.9%, 95% CI: 10.6-29.2). Lupus Low Level Disease Activity State (LLDAS) at week 52 weeks also more than doubled with Gazyva/Gazyvaro compared to placebo (57.6% versus 25.0%, adjusted difference 32.6%, 95% CI: 22.3-43.0).
