Abbvie Announces Venetoclax Receives 3rd Breakthrough Therapy Designation from the FDA

AbbVie ABBV announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for the investigational agent venetoclax in combination with hypomethylating agents (HMAs) for the treatment of patients with untreated (treatment-naïve) acute myeloid leukemia (AML) who are ineligible to receive standard induction therapy (high-dose chemotherapy). Venetoclax is an inhibitor of the B-cell lymphoma-2 (BCL-2) protein being developed by AbbVie in partnership with Genentech and Roche. "Acute myeloid leukemia is an aggressive and life- threatening cancer. Unfortunately, for many AML patients, intensive therapy is not an option, causing a high need for new, effective, and alternative treatments," said Michael Severino, M.D., executive vice president of research and development and chief scientific officer, AbbVie. "This third Breakthrough Therapy Designation for venetoclax highlights our efforts to pursue the significant and broad potential of this therapy." AML is characterized by the body producing too many of a specific type of white blood cell (myeloblast) which can crowd out healthy blood cells.1 In the See full press release