The Food and Drug Administration (FDA) has approved Venclexta (venetoclax; AbbVie and Genentech) for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion who have received at least 1 prior therapy. It is intended for use after detection of 17p deletion by an FDA-approved companion diagnostic, Vysis CLL FISH probe kit. 

Venetoclax is the first FDA-approved selective and orally bioavailable small-molecule inhibitor of BCL-2, an antiapoptotic protein. Overexpression of BCL-2 has been demonstrated in CLL cells where it mediates tumor cell survival and has been associated with resistance to chemotherapeutics. Venetoclax helps restore the process of apoptosis by binding directly to the BCL-2 protein, displacing pro-apoptotic proteins like BIM, triggering mitochondrial outer membrane permeabilization and the activation of caspases.

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Efficacy was evaluated in a single-arm clinical trial (n=106) in CLL patients who have a 17p deletion and who had received at least one prior therapy. Study patients were orally administered Venclexta daily, starting with 20mg and increasing to 400mg over a 5-week period. The data showed 80% of study patients experienced a complete or partial remission of their cancer. 

“Up to half of people whose CLL progressed have 17p deletion, a genetic marker that makes the disease difficult-to-treat,” said Sandra Horning, MD, chief medical officer and head of Global Product Development of Genentech. “Venclexta is the first approved medicine designed to trigger a natural process that helps cells self-destruct, and is a new way to help people who have been previously treated and have this high-risk form of the disease.”   

Venclexta was granted Breakthrough Therapy designation, Priority Review status, Orphan Drug designation, and accelerated approval for this indication. It will be available as 10mg, 50mg, and 100mg strength tablets. Venclexta should be initiated at a dose of 20mg once daily for 7 days followed by a 5-week ramp-up schedule until reaching the recommended daily dose of 400mg.

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