Biotech Values

[DewDiligence]

(HALO)—FDA advisory panel backs subcutaneous formulation of Rituxan:

https://www.gene.com/media/press-releases/14658/2017-03-29/fda-advisory-committee-unanimously-recom

….(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, 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).

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.

“Subcutaneous rituximab can be administered in five to seven minutes compared to an hour and a half or more for intravenous Rituxan,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development.

This reformulation is part of Roche’s “lifecycle management” strategy to defend against Rituxan FoBs.