Roche submits obinutuzumab applications

Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit submitted regulatory applications to FDA and EMA for obinutuzumab ( GA101) to treat chronic lymphocytic leukemia (CLL). The submissions were based on data from the Phase III CLL11 trial which showed that obinutuzumab plus chlorambucil chemotherapy met the primary endpoint of improving median progression-free survival (PFS) vs. chlorambucil alone in Stage 1a of the trial (23 vs. 10.9 months, p<0.0001). Data from the trial are slated to be presented at the American Society of Clinical Oncology meeting in June. Genentech previously said obinutuzumab met the primary endpoint in the trial, but did not provide details (see BioCentury Extra, Jan. 31, 2013).

Genentech also said FDA granted breakthrough therapy designation for obinutuzumab to treat CLL. The glycoengineered humanized mAb against CD20 is also in Phase III testing for non-Hodgkin's lymphoma (NHL) and diffuse large B cell lymphoma (DLBCL). Genentech is co-developing obinutuzumab in the U.S. with Biogen Idec Inc. (NASDAQ:BIIB). Roche gained the product, which was developed using GlycoMAb glycosylation technology, through its 2005 acquisition of Glycart Biotechnology AG. ...