BioCentury
ARTICLE | Company News

Roche's obinutuzumab gets Priority Review for CLL

July 3, 2013 11:13 PM UTC

FDA accepted and granted Priority Review to a BLA from Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit for obinutuzumab ( GA101) to treat previously untreated chronic lymphocytic leukemia (CLL). The PDUFA date is Dec. 20. FDA granted the glycoengineered humanized mAb against CD20 breakthrough therapy designation for the indication in May. The companies submitted an MAA to EMA for obinutuzumab in April (see BioCentury, June 10). ...