Investigational medicine Venetoclax receives Breakthrough Therapy Designation from the FDA

WASHINGTON - May 8, 2015 - PRLog -- The investigational drug venetoclax has been granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) in relapsed of refractory chronic lymphocytic leukemia in previously treated patients with 17P deletion genetic mutation. Breakthrough Therapy Designation is intended to accelerate the research and development process for drugs designed to treat serious or life threatening conditions.

Venetoclax is an investigational oral B-cell lymphoma-2 (BCL-2) being co-developed between AbbVie and Genentech/Roche to treat various cancer types. Venetoclax has been engineered to selectively inhibit the function of the BCL- 2 protein which prevents apoptosis of lymphocytes.  In CLL patients, the cancer typically progresses more slowly than other types of leukemia and the bone marrow makes too many abnormal lymphocytes.

"The Breakthrough Therapy Designation of venetoclax supports the continued development of this investigational medicine in CLL patients with 17p deletion," said Michael Severino, M.D., executive vice president of research and development and chief scientific officer, AbbVie. "The continuing advancement of the venetoclax development program is one example of AbbVie's focus on delivering innovative medicines that address unmet clinical needs.”

Venetoclax is still undergoing Phase 2 and Phase 3 clinical trials to treat CLL and other forms of cancer. Abbvie is expected to submit U.S. and European regulatory applications for the treatment by the end of 2015.

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