Roche’s Gazyva gains EU panel backing after 76.7% lupus response

Roche said Friday, Nov. 13, that the CHMP recommended EU approval of Gazyva/Gazyvaro after 76.7% of treated lupus patients met the ALLEGORY trial’s main response measure at 52 weeks.

The recommendation matters because systemic lupus erythematosus affects more than three million people worldwide and up to 270,000 in Europe, according to Roche’s press release, while the placebo response in ALLEGORY was 53.5%.

The European Medicines Agency’s Committee for Medicinal Products for Human Use backed Gazyva/Gazyvaro, also known as obinutuzumab, as an add-on treatment for adults with moderate-to-severe, active, autoantibody-positive SLE despite standard therapy. The European Commission makes the final approval decision.

ALLEGORY was a phase III, randomised, double-blind, placebo-controlled, multicentre study in about 300 adults with SLE on standard therapy. Participants were assigned 1:1 to receive Gazyva/Gazyvaro or placebo for up to 52 weeks, followed by an open-label period with Gazyva/Gazyvaro for up to 104 weeks.

The primary endpoint was SRI-4, a composite measure requiring at least a four-point improvement in the SLE Responder Index at week 52. Roche said 76.7% of patients receiving Gazyva/Gazyvaro plus standard therapy achieved that endpoint, compared with 53.5% on placebo plus standard therapy, an adjusted difference of 23.1 percentage points with a 95% confidence interval of 12.5 to 33.6 and p<0.001.

“Many people with systemic lupus erythematosus experience recurring flares, progressive organ damage, and chronic steroid dependence,” Levi Garraway, Roche's Chief Medical Officer and Head of Global Product Development, said in the release. “This positive CHMP recommendation brings Gazyva/Gazyvaro a step closer to offering people with SLE a new option that may achieve meaningful and sustained disease control.”

Roche said the drug also performed better than placebo across key secondary endpoints, including BICLA response, sustained glucocorticoid reduction, sustained SRI-4 response, SRI-6 response and time to first disease flare. On the DORIS remission standard, 33.8% of patients on Gazyva/Gazyvaro achieved remission compared with 13.8% on placebo, an adjusted difference of 19.9 percentage points with a 95% confidence interval of 10.6 to 29.2.

The company also reported that 57.6% of treated patients reached Lupus Low Disease Activity State, compared with 25.0% in the placebo group, an adjusted difference of 32.6 percentage points. Roche said ALLEGORY identified no new safety signals and described the safety profile as consistent with the drug’s established profile.

Gazyva/Gazyvaro is a humanised monoclonal antibody designed to target CD20, a protein found on some B cells. Roche said the drug is already approved for adults with lupus nephritis in more than 65 countries and for various haematological cancers in 100 countries.

The study cannot show whether the 52-week blinded results translate into longer-term protection from organ damage or reduced steroid exposure beyond the trial period described by Roche. The company’s release did not specify trial funding or declared conflicts.

Roche said the U.S. Food and Drug Administration accepted its supplemental Biologics License Application for Gazyva/Gazyvaro in SLE earlier this year. The company said a final European Commission decision is expected in the near future, but did not give a date.

Source: company press release, Roche, Nov. 13, 2026

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