Roche wins USFDA breakthrough status for Gayzva for lupus nephritis

Roche Gazyva 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.

New Delhi: Roche has won the U.S. Food and Drug Administration's breakthrough therapy tag for its drug Gazyva in lupus nephritis, the Swiss drugmaker said on Wednesday, boosting its efforts to recycle the 2013-approved lymphoma medicine for new indications.

This designation was granted based on data from the phase II NOBILITY study in adult patients with proliferative lupus nephritis which showed Gazyva, in combination with standard of care (mycophenolate mofetil or mycophenolic acid and corticosteroids), demonstrated enhanced efficacy compared to placebo plus standard of care alone in achieving complete renal response at one year.

Gazyva 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 United States, Gazyva is part of a collaboration between Genentech and Biogen. Combination studies investigating Gazyva with other approved or investigational medicines, including cancer immunotherapies and small molecule inhibitors, are underway across a range of blood cancers.

Lupus nephritis is a potentially life-threatening manifestation of systemic lupus erythematosus resulting from inflammation of the kidneys and is associated with a high risk of end-stage renal disease or death.

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. This is the 27th Breakthrough Therapy Designation for Roche’s portfolio of medicines.

Commenting on the same, Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development said, “New treatment options are needed for lupus nephritis, a potentially life-threatening inflammation of the kidneys that most commonly affects women. 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.”

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