publication date: May. 2, 2016

Drugs and Targets Accelerated Approval Granted to Venclexta Tablets in CLL


FDA granted accelerated approval to Venclexta tablets (venetoclax) for patients diagnosed with chronic lymphocytic leukemia with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy.

The indication was approved 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 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 will become commercially available in the U.S. within a week.

FDA granted priority review for the NDA application of venetoclax as a single agent in January. The FDA also granted venetoclax three Breakthrough Therapy designations: for the treatment of CLL in previously treated … Continue reading CCL April – Accelerated Approval Granted to Venclexta Tablets in CLL

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