Genentech, a member of the Roche Group, has obtained FDA priority review status for Obinutuzumab (GA101) to treat previously untreated chronic lymphocytic leukemia (CLL).
The FDA has also accepted the company's biologics license application (BLA) for obinutuzumab with decision expected by the end of 2013.
Designed to attack cells with certain markers on the surface, the investigational medicine kills targeted cells both directly and mutually with the body's immune system.
The decision was based on the positive final stage 1 data from pivotal Phase III CLL11 trial in which GA101 demonstrated a statistically significant 86% reduction in the risk of disease worsening or death in combination with chlorambucil chemotherapy against chlorambucil alone.
Genentech global product development head and chief medical officer Dr Hal Barron said, "These FDA designations acknowledge the promising trial results with GA101 and will hopefully allow this novel medicine to reach the people who need it in an expedited time frame."
A large clinical program, including multiple head-to-head Phase III studies versus rituximab in indolent non-Hodgkings lymphoma and diffuse large B-cell lymphoma, is currently evaluating GA101.
