Roche lymphoma med gets nod from FDA panel
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.