FDA advisory committee unanimously recommends approval of Roche ’s subcutaneous rituximab for certain blood cancers

Roche announced today 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 favourable 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).
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news