AbbVie announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Venclexta™ (venetoclax) tablets for patients diagnosed with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy. The FDA approved this indication under accelerated approval based on overall response rate, and continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial. The FDA approved Venclexta as a first-in-class, oral, once-daily medicine that selectively inhibits the BCL-2 protein. The BCL-2 protein blocks apoptosis (programmed cell death) of cells, including some cancer cells, and can be overexpressed in CLL cells.Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is marketed collaboratively by the companies in the U.S. and by AbbVie outside of the U.S.
AbbVie expects Venclexta, a tablet taken orally, will become commercially available in the U.S. within a week.
In January 2016, AbbVie announced that the FDA granted priority review for the NDA application of venetoclax as a single agent.The FDA also granted venetoclax three Breakthrough Therapy designations the first for venetoclax for the treatment of chronic lymphocytic leukemia (CLL) in previously treated (relapsed/refractory) patients with the 17p deletion genetic mutation,7 the second for venetoclax in combination with rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL), and the third for patients with untreated (treatment-naïve) acute myeloid leukemia (AML) who are ineligible to receive standard induction therapy (high-dose chemotherapy). According to the FDA, Breakthrough Therapy designation is intended to expedite the development and review of therapies for serious or life-threatening conditions.
Additionally, in January 2016, AbbVie announced that the European Medicines Agency (EMA) had validated its Marketing Authorization Application (MAA) for venetoclax for the treatment of patients with CLL with 17p deletion or TP53 mutation.
