Roche Secures European Commission Approval For Obinutuzumab Combo Therapy, Marking A Major Advancement In Lupus Nephritis Treatment

Roche announced that the European Commission has approved Gazyva/Gazyvaro (obinutuzumab) in combination with mycophenolate mofetil (MMF) for adults with active Class III or IV lupus nephritis, with or without co-existing Class V disease. These classifications reflect the severity and pattern of kidney involvement, which is central to the prognosis of lupus nephritis. The decision marks a major step forward in providing new options for a patient population facing high disease burden and progressive organ damage.

“This approval marks a major advance in the treatment of lupus nephritis for people across Europe who wrestle with this disease,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “By controlling disease activity, Gazyva/Gazyvaro could help delay or prevent progression to end-stage kidney disease and the need for dialysis or transplant, underscoring its potential to become a new standard of care in Europe.”

The approval is supported by compelling evidence from the phase II NOBILITY and phase III REGENCY studies. In REGENCY, results published in the New England Journal of Medicine showed that 46.4% of patients receiving Gazyva/Gazyvaro plus standard therapy achieved a complete renal response, compared with 33.1% of those on standard therapy alone. Treatment with Gazyva/Gazyvaro resulted in meaningful reductions in corticosteroid use, improvements in proteinuria, and favourable shifts in biological markers, such as complement levels and anti-dsDNA, all indicators of improved disease control. The safety profile remained consistent with what has already been observed in its oncology indications.

Lupus nephritis remains a serious and potentially life-threatening manifestation of systemic lupus erythematosus, disproportionately affecting women of colour of childbearing age. Across the EU, an estimated 135,000 people live with this condition, and up to one third may progress to end-stage kidney disease within a decade, requiring dialysis or transplant. As such, more effective treatments such as Gazyva/Gazyvaro may help delay or prevent long-term organ failure.

“The symptoms of lupus nephritis and their unpredictable nature can impact quality of life, emotional wellbeing and limit future family and career prospects,” said Jeanette Andersen, Chair of Lupus Europe. “This approval for Gazyva/Gazyvaro offers a much needed treatment that may help ease the burden of living with this complex disease and reflects the vital role of patient community experts in trial development.”

This EU approval follows the 2025 FDA approval for Gazyva/Gazyvaro in active lupus nephritis. Additional phase III data in childhood idiopathic nephrotic syndrome and adult systemic lupus erythematosus further support the medicine’s broad potential in immune-mediated diseases. Roche continues to evaluate Gazyva/Gazyvaro across multiple age groups and kidney-related conditions as part of its expanding commitment to autoimmune and nephrology research.