The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to AbbVie’s investigational agent venetoclax (ABT-199) for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) in patients with 17p deletion.
Venetoclax is an investigational oral B-cell lymphoma-2 (BCL-2) inhibitor currently being evaluated for the treatment of patients with a number of different cancers. The drug is designed to selectively inhibit the BCL-2 protein, which prevents apoptosis of some cells, including lymphocytes, and can be expressed in some cancer types.
Breakthrough Therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. ■