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Roche lymphoma med gets nod from FDA panel

March 30, 2017

Roche Holding AG’s RHHBY member, Genentech announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) has recommended the approval of subcutaneous Rituxan /hyaluronidase for the treatment of patients with certain blood cancers. The indications include previously untreated follicular lymphoma and 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). The FDA is expected to make a decision on approval by June 26, 2017.

The new co-formulation contains the same monoclonal antibody as intravenous Rituxan and hyaluronidase, a molecule that helps to deliver medicine under the skin.


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