Roche's GA101 first approved breakthrough

FDA approved a BLA from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) for Gazyva obinutuzumab ( GA101) in combination with chlorambucil to treat previously untreated chronic lymphocytic leukemia (CLL). Gazyva is the first product with breakthrough therapy designation to be approved by the agency. Gazyva's label includes a boxed warning on the risk of the reactivation of HBV infection and progressive multifocal leukoencephalopathy (PML). Genentech plans to launch the glycoengineered humanized mAb against CD20 in the U.S. in the next two weeks, with a wholesale acquisition cost (WAC) of $41,300 for a six-month course of treatment (see BioCentury, June 10).

FDA granted breakthrough therapy designation to Gazyva around the same time Genentech submitted the BLA to the agency in May. Corporate spokesperson Krysta Pellegrino said the company still benefited from the designation through "frequent and collaborative meetings with FDA." Pellegrino also said the designation may have contributed to Gazyva's early approval. The BLA was under Priority Review, with a Dec. 20 PDUFA date. ...