— AbbVie plans to submit regulatory applications for venetoclax to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) before the end of 2015
— Venetoclax is currently in development for the treatment of relapsed or refractory chronic lymphocytic leukemia, including patients with 17p deletion
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May 6, 2015
NORTH CHICAGO, Ill., May 6, 2015 /PRNewswire/ — AbbVie (NYSE: ABBV) reported its investigational medicine venetoclax, an inhibitor of the B-cell lymphoma-2 (BCL-2) protein that is being developed in partnership with Genentech and Roche, has been granted Breakthrough Therapy Designation by the FDA for the treatment of chronic lymphocytic leukemia (CLL) in previously treated (relapsed/refractory) patients with the 17p deletion genetic mutation (Press release, AbbVie, MAY 6, 2015, View Source [SID:1234503964]).
CLL is a slow-progressing cancer of the bone marrow and blood in which the bone marrow makes too many lymphocytes, a type of white blood cell.1 CLL accounts for approximately one quarter of the new cases of leukemia diagnosed in the United States.2 Approximately 3-10 percent of CLL patients have 17p deletion at diagnosis, and it occurs in 30-50 percent of patients with relapsed/refractory CLL.3 The 17p deletion mutation is a genomic alteration in which a part of chromosome 17 is absent.4 The median life expectancy for CLL patients with 17p deletion is less than 2-3 years.5
"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."
According to the FDA, Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for Breakthrough Therapy Designation includes preliminary clinical evidence demonstrating a drug may have substantial improvement on at least one clinically significant endpoint compared to available therapy. A Breakthrough Therapy Designation conveys all of the fast track program features, as well as more intensive FDA guidance on an efficient drug development program.
Additional information regarding the venetoclax clinical trials is available on www.clinicaltrials.gov.
About Venetoclax
Venetoclax is an investigational oral B-cell lymphoma-2 (BCL-2) inhibitor being evaluated for the treatment of patients with various cancer types. The BCL-2 protein prevents apoptosis of some cells, including lymphocytes, and can be expressed in some cancer types. Venetoclax is designed to selectively inhibit the function of the BCL-2 protein. Venetoclax is being developed in collaboration with Genentech and Roche. Together, the companies are committed to BCL-2 research with venetoclax, which is currently being evaluated in Phase 2 and Phase 3 clinical trials for the treatment of CLL, along with studies in several other cancers. Venetoclax is an investigational compound and its safety and efficacy have not been evaluated by the FDA or any other health authority.
About AbbVie Oncology
AbbVie’s oncology research is focused on the discovery and development of targeted therapies that work against the processes cancers need to survive. By investing in new technologies and approaches, AbbVie is breaking ground in some of the most widespread and difficult-to-treat cancers, including multiple myeloma and chronic lymphocytic leukemia. AbbVie’s oncology pipeline includes multiple new molecules in clinical trials being studied in more than 15 different cancers and tumor types. For more information on AbbVie’s oncology portfolio, please visit View Source