FDA Gives Priority Review for Genentech Leukemia Drug

Jan. 13, 2016

Genentech, a member of the Roche Group, announced that the U.S. FDA has accepted the New Drug Application and granted Priority Review for venetoclax for the treatment of people with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, including those with 17p deletion.

Venetoclax is a small molecule inhibitor of the BCL-2 protein being developed in partnership with AbbVie, and was granted Breakthrough Therapy Designation by the FDA in April 2015 for the treatment of people with previously treated (relapsed or refractory) CLL with 17p deletion.

“Venetoclax is a potential new way to treat this difficult type of chronic lymphocytic leukemia,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We look forward to working with AbbVie and health authorities to bring this first-of-its-kind medicine to people who need more options.”

A Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.