FDA Advisory Committee Votes for Approval of Genentech’s Subcutaneous Rituximab for Certain Blood Cancers

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April 12, 2017

Genentech reported that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted unanimously (11 to 0) that the benefit-risk of rituximab/hyaluronidase for subcutaneous (under the skin) injection was favorable for the treatment of certain blood cancers, which include: previously untreated follicular lymphoma, previously untreated diffuse large B-cell lymphoma (DLBCL), relapsed or refractory low grade or follicular lymphoma, and previously untreated and relapsed or refractory chronic lymphocytic leukemia (CLL).

According to a media release, this new co-formulation includes the same monoclonal antibody as intravenous Rituxan (rituximab) and hyaluronidase, a molecule that helps to deliver medicine under the skin. The FDA is expected to make a decision on approval by June 26.

“Subcutaneous rituximab can be administered in five to seven minutes compared to an hour and a half or more for intravenous Rituxan,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “The significant reduction in administration time could especially benefit people with blood cancer who may receive years of treatment, and we are pleased the committee unanimously supported this new co-formulation.”

Genentech said that this co-formulation has been available in the European Union since 2014 where it is known as the subcutaneous (SC) formulation of MabThera (rituximab) and is approved in approximately 50 other countries worldwide. In the United States, Rituxan is currently approved as an intravenous formulation for the treatment of people with previously untreated follicular lymphoma, previously untreated DLBCL, relapsed or refractory low grade or follicular lymphoma, and previously untreated and relapsed or refractory CLL. Intravenous Rituxan will continue to be available to patients if subcutaneous rituximab is approved. The committee’s vote does not affect intravenous Rituxan’s approved uses in the United States or in other countries.

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