FDA approves Gazyva/Gazyvaro (obinutuzumab) for the treatment of lupus nephritis – Roche

Roche announced  that the FDA  has approved Gazyva/Gazyvaro (obinutuzumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy, as well as a shorter 90-minute infusion time after the first infusion, for eligible patients. Following four initial doses in the first year, Gazyva/Gazyvaro can be administered twice yearly, offering an effective and potentially more convenient treatment option than traditional targeted therapies.

The recommendation is based on positive results from the phase II NOBILITY and phase III REGENCY studies. In REGENCY, data showed that nearly half of the participants (46.4%) on Gazyva/Gazyvaro plus standard therapy (mycophenolate mofetil and glucocorticoids) achieved a complete renal response (CRR) compared to 33.1% on standard therapy alone. This was accompanied by a statistically significant and clinically meaningful reduction of corticosteroid use, and an improvement in proteinuric response, all signalling improved disease control. The safety profile of Gazyva/Gazyvaro was consistent with the well-characterised profile observed in its haematology-oncology indications.

REGENCY [NCT04221477] is a phase III, randomised, double-blind, placebo-controlled, multicentre study investigating the efficacy and safety of Gazyva/Gazyvaro (obinutuzumab) plus standard therapy (mycophenolate mofetil and glucocorticoids) in people with active/chronic International Society of Nephrology/Renal Pathology Society 2003 proliferative Class III or IV lupus nephritis, with or without Class V. The study enrolled 271 people, who were randomised 1:1 to receive either Gazyva/Gazyvaro plus standard therapy or placebo plus standard therapy. REGENCY was designed based on robust phase II data and conducted during the COVID-19 pandemic. The study population was representative of the real-world population of people with lupus nephritis.

“People with lupus nephritis who achieve a complete renal response are more likely to experience preserved kidney function and delay, or even prevention, of progression to end-stage kidney disease,” said Dr. Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. “The approval of Gazyva/Gazyvaro by the FDA marks an important step towards a potential new standard of care for lupus nephritis, one that could allow clinicians to offer their patients more effective disease control.”

“As a severe and potentially life-threatening disease, lupus nephritis greatly disrupts daily life with chronic pain, fatigue, and the constant fear of worsening kidney health,” said Louise Vetter, President and Chief Executive Officer, Lupus Foundation of America. “The FDA’s approval of Gazyva/Gazyvaro offers renewed hope for people with lupus nephritis and their loved ones, as it provides an important new treatment option that has the potential to prevent long-term complications, including kidney failure.”