AbbVie's Venetoclax Receives Breakthrough Therapy Designation from FDA in Combination with Rituximab for the Treatment of Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia

NORTH CHICAGO, Ill., Jan. 20, 2016 /PRNewswire/ -- AbbVie (NYSE:ABBV), a global biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for venetoclax in combination with rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL). Venetoclax is an inhibitor of the B-cell lymphoma-2 (BCL-2) protein being developed by AbbVie in partnership with Genentech and Roche.

The designation is supported by an investigational study of venetoclax in combination with rituximab in patients with R/R CLL. Rituximab is indicated in combination with fludarabine and cyclophosphamide for the treatment of patients with previously untreated and previously treated CD20-positive CLL.  Rituximab in combination with the investigational agent venetoclax is not approved for the treatment of R/R CLL.

In the U.S. specifically, it is estimated that more than 14,000 people will be diagnosed with CLL this year.¹

In April 2015, the FDA granted Breakthrough Therapy Designation to single agent venetoclax for the treatment of CLL in previously treated (relapsed/refractory) patients with the 17p deletion genetic mutation. According to the FDA, Breakthrough Therapy Designation is intended to expedite the development and review of therapies for serious or life-threatening conditions. In January, AbbVie announced that the FDA granted priority review for the single agent NDA application.

"This second Breakthrough Therapy Designation for venetoclax granted by the FDA underscores the significant potential of this therapy in treating relapsed/refractory CLL patients, and reflects AbbVie's commitment to providing breakthrough therapies for cancer patients," said Michael Severino, M.D., executive vice president of research and development and chief scientific officer, AbbVie. "AbbVie will continue harnessing our collective expertise to accelerate efforts to bring new treatment options to patients battling this difficult to treat blood cancer."

Additional information regarding the venetoclax clinical trials is available on www.clinicaltrials.gov.

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 glioblastoma multiforme, 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 Oncology, please visit http://oncology.abbvie.com.

About Chronic Lymphocytic Leukemia (CLL)
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. CLL is the most common type of leukemia in the Western world.1 In the U.S. specifically, it is estimated that more than 14,000 people will be diagnosed with CLL this year.1

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 (programmed cell death) of some cells, including lymphocytes, and can be over 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 3 clinical trials for the treatment of relapsed/refractory 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. Earlier this month, AbbVie announced the FDA granted priority review for the evaluation of the venetoclax NDA application for the treatment of chronic lymphocytic leukemia (CLL) in adults who have received at least one prior therapy, including patients with 17p deletion. The company also announced that the Marketing Authorization Application (MAA) for venetoclax was validated by the European Medicines Agency (EMA) for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion or TP53 mutation.

About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries.

For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

Forward-Looking Statements 
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. 

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2014 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

¹ American Cancer Society (2015). "Leukemia – Chronic Lymphocyctic." http://www.cancer.org/acs/groups/cid/documents/webcontent/003111-pdf.pdf, Accessed January 18, 2016.

SOURCE AbbVie

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