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Gazyva Designated a Breakthrough Therapy for Lupus

Roche Drug Outperformed Standard of Care in Phase 2 Study

The FDA has awarded a breakthrough therapy designation to obinutuzumab (Gazyva, Roche) for the treatment of adults with lupus nephritis.

The decision was based on data from the phase 2 NOBILITY study in adults with proliferative lupus nephritis. Obinutuzumab, in combination with the standard of care (mycophenolate mofetil or mycophenolic acid and corticosteroids), produced better results than placebo plus standard of care in achieving a complete renal response at one year. Full results from the study will be presented at a future medical meeting. Roche plans to begin enrolling patients in a phase 3 trial next year.

Lupus nephritis, a severe and potentially life-threatening disorder of the kidneys, is a complication of systemic lupus erythematosus (SLE), in which a person's own immune system attacks healthy cells and organs. Up to 60% of people with SLE will develop lupus nephritis, and up to 25% of people with the condition develop end-stage renal disease. Lupus overwhelmingly affects women. There is no cure for lupus or lupus nephritis.

The FDA’s breakthrough therapy designation is designed to accelerate the development and review of medicines intended to treat serious or life-threatening conditions with preliminary evidence that indicates they may demonstrate a substantial improvement over existing therapies.

Obinutuzumab is an engineered monoclonal antibody designed to attach to CD20, a protein found only on certain types of B-cells. It is thought to work by attacking targeted cells both directly and together with the body's immune system. In the U.S., it is indicated in combination with other drugs for the treatment of certain patients with chronic lymphocytic leukemia and follicular lymphoma. It has a boxed warning about the risk of hepatitis B virus reactivation and progressive multifocal leukoencephalopathy, both potentially fatal.  

Sources: Roche, September 18, 2019; Gazyva Prescribing Information, November 2017

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