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

30 March 2017

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.

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