ROCHE’S SUBCUTANEOUS RITUXIMAB GETS UNANIMOUS RECOMMENDATION FROM FDA ADVISORY COMMITTEE

U.S. FDA News

In a press release, Roche announced today that FDA’s Oncologic Drug Advisory Committee has voted unanimously in favor of a subcutaneous injection of rituximab for the treatment of certain blood cancers, including 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). A new co-formulation of the same monoclonal antibody as in intravenous Rituxan® and hyaluronidase enzyme, Roche’s product is marketed under the MabThera® SC brand in Europe and many other countries outside the U.S. The FDA’s decision on approval is expected by June 26, 2017.

 

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