FDA panel to discuss binimetinib, subcutaneous rituximab
FDA’s Oncologic Drugs Advisory Committee will meet on March 29 to discuss a BLA from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) for subcutaneous rituximab, as well as an NDA from Array BioPharma Inc. (NASDAQ:ARRY) for binimetinib (MEK162).
Subcutaneous rituximab is under review to treat follicular lymphoma, diffuse large B cell lymphoma (DLBCL) and chronic lymphocytic leukemia (CLL), with a June 26 PDUFA date. Genentech and Biogen Inc. (NASDAQ:BIIB) co-market IV rituximab as Rituxan in the U.S. The subcutaneous formulation uses Enhanze recombinant human hyaluronidase (rHuPH20) drug delivery technology from Halozyme Therapeutics Inc. (NASDAQ:HALO), and is approved in the EU. Rituximab is a chimeric mAb against CD20 antigen...