Genentech's subcutaneous rituximab gets unanimous FDA panel backing for certain blood cancers

The Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) voted unanimously (11 to 0) that the benefit-risk of rituximab/hyaluronidase for subcutaneous injection was favorable for the treatment of certain blood cancers.

This means backing for rituximab, from Swiss pharma giant Roche (ROG: SIX) subsidiary Genentech, for conditions such as 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).

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, 2017.