publication date: Apr. 18, 2016

FDA Grants Accelerated Approval 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 patients with the 17p deletion genetic mutation; in combination with rituximab for the treatment of patients with relapsed/refractory CLL; and for patients with untreated acute myeloid leukemia who are ineligible to receive standard induction therapy.

The safety and efficacy of Venclexta was evaluated in an open-label, multicenter clinical trial of 106 previously-treated CLL patients with 17p deletion. In the study, patients with 17p deletion were identified using Vysis CLL FISH Probe Kit.

Continue reading 42-15 FDA Grants Accelerated Approval to Venclexta Tablets in CLL

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