Jan 12, 2016. The U.S. Food and Drug Administration (FDA) has 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.
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. A priority review means that the FDA plans to take action on the drug’s application within 6 months, rather than the standard 10 months allotted for a regular review period.
Venetoclax is a BCL-2 inhibitor that is being co-developed by AbbVie and Genentech.