Subcutaneous Rituximab Seems Headed For US FDA Advisory Panel OK

28 Mar 2017

• By Michael Cipriano

Genentech used pharmacokinetic bridging studies for new route of administration, which uses the enzyme hyaluronidase and is strongly preferred by patients over the IV; firm is seeking indications for follicular lymphoma, diffuse large B-cell lymphoma and chronic lymphocytic leukemia.

The US FDA's Oncologic Drugs Advisory Committee will convene March 29 to assess the acceptability of Genentech Inc.’s pharmacokinetic bridging development program for its subcutaneously administered monoclonal antibody rituximab – a discussion that could have implications for biosimilars as well as the oncology market.

Rituximab was initially approved by FDA in 1997 in intravenous form under the brand name Rituxan, and is indicated for...