Obinutuzumab Receives Breakthrough Therapy Designation from FDA

The FDA has granted Obinutuzumab (Gazyva, Genentech) a Breakthrough Therapy Designation (BTD) for its potential use in the treatment of adult with lupus nephritis. 

Obintuzumab, originally approved in 2013 a treatment for various forms of lymphoma, is an engineered monoclonal antibody designed to attach to the CD20 protein. The antibody is thought to work by directly attacking targeted cells, as well as working in conjunction with the body’s immune system, according to a recent release. 

The recent BTD stems from the results of Genentech’s Phase 2, randomized, double-blind, placebo-controlled, multi-center study NCT02550652. The trial measured the safety and efficacy of obinutuzumab in combination with mycophenolate mofetil (MMF) or mycophenolic acid (MPA) and corticosteroids, as compared to placebo with MMF or MPA. The primary endpoint of the study was the proportion of participants who achieved a protocol-defined complete renal response (CRR) at 52 weeks.

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According to a release, the study met its primary endpoint, showing that obinutuzumab, in combination with MMF or MPA, demonstrated an enhanced efficacy in achieving a complete renal response at one year. Secondary endpoints met included the improvement of the overall renal responses and serological makers of disease activity as compared to placebo. No new safety signals were observed in the study. Full results of the study are expected to be reported at a later medical meeting. 

“New treatment options are needed for lupus nephritis, a potentially life-threatening inflammation of the kidneys that most commonly affects women,” says Sandra Horning, MD, chief medical officer and head of Global Product Development, in a statement. “We are committed to developing Gazyva as a potential new therapy for lupus nephritis and plan to begin enrolling patients in a Phase III trial next year.”

Obinutuzumab is contraindicated in patients with a known hypersensitivity to obinutuzumab or any of its excipients, including serum sickness with prior use. 

A boxed warning for obinutuzumab includes the potential for Hepatitis B reactivation that may lead to fulminant hepatitis, hepatic failure, and death; and progressive multifocal leukoencephalopathy, resulting in death. 

Full Prescribing Informatiton

For more inforamtion on lupus nephritis, visit our sister site, Rhuematology Network:

• Nephritis Sets in Early in Lupus, Treatment Guidelines Can Stave Off Worsening Condition

• More Lupus Nephritis Trials Underway