September 18, 2019
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Gazyva Receives FDA Breakthrough Therapy Designation for Lupus Nephritis

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Jay Garg, MD
Jay Garg

The FDA has granted Gazyva breakthrough therapy designation for the treatment of adult patients with lupus nephritis, according to a Genentech press release.

Originally approved by the FDA in 2013 for the treatment of adults with previously untreated chronic lymphocytic leukemia, Gazyva (obinutuzumab, Genentech) was subsequently approved in 2017 for the treatment of adults with previously untreated advanced follicular lymphoma. For the purpose of treating complications linked to systemic lupus erythematosus, the breakthrough designation pairs Gazyva with standard of care practices, such as mycophenolate mofetil or mycophenolic acid and corticosteroids.

“The FDA’s decision is an important milestone in our over decade-long commitment to researching potential therapies for lupus and lupus nephritis,” Jay Garg, MD, group medical director in product development for immunology, infectious diseases and ophthalmology at Genentech, told Healio Rheumatology. “We are looking forward to meeting with health authorities to discuss how best to bring this therapy to people with lupus nephritis, who currently have no FDA-approved medicines available.”

The FDA based its designation on results from the randomized, double-blind, placebo-controlled phase 2 NOBILITY trial comparing the safety and efficacy of Gazyva plus standard of care — mycophenolate mofetil or mycophenolic acid and corticosteroids — against standard of care plus placebo among adult patients (n = 126) with proliferative lupus nephritis. The primary endpoint was the proportion of patients who attained a complete renal response at 52 weeks.

According to study results, Gazyva plus standard of care demonstrated enhanced efficacy vs. placebo plus standard of care in achieving complete renal response at 1 year. Additionally, Gazyva demonstrated improved overall renal responses and serologic markers of disease activity compared with placebo.

Sandra Horning, MD
Sandra Horning

“New treatment options are needed for lupus nephritis, a potentially life-threatening inflammation of the kidneys that most commonly affects women,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in a press release. “We are committed to developing Gazyva as a potential new therapy for lupus nephritis and plan to begin enrolling patients in a phase 3 trial next year.”

Based on safety trials conducted among patients with relapsed or refractory non-Hodgkin lymphoma, the most common adverse events observed with Gazyva were injection site reactions, low white blood cell counts, low platelet counts, low red blood cell counts, fever, cough, nausea, and diarrhea.