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AbbVie Receives CHMP Positive Opinion for VENCLYXTO™ (venetoclax) Tablets for Appropriate Patients with Difficult-To-Treat Chronic Lymphocytic Leukaemia

Freitag, 14.10.2016 13:30 von

PR Newswire

- CHMP recommends VENCLYXTO monotherapy for the treatment of chronic lymphocytic leukaemia (CLL) in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor; and in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemo-immunotherapy and a B-cell receptor pathway inhibitor

- If granted conditional marketing authorization by the European Commission, VENCLYXTO would become the first approved BCL-2 inhibitor in Europe

- COMP recently adopted positive opinions for VENCLYXTO Orphan Drug Designation for the treatment of multiple myeloma and diffuse large B-cell lymphoma (DLBCL)

NORTH CHICAGO, Illinois, Oct. 14, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the European Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion for VENCLYXTO™ (venetoclax) tablets for the treatment of chronic lymphocytic leukaemia (CLL) in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor; and for the treatment of CLL in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemo-immunotherapy and a B-cell receptor pathway inhibitor. The European Commission will review the opinion and make a final decision in late 2016. VENCLYXTO is being developed by AbbVie and Genentech, a member of the Roche Group.

"People living with CLL who have failed other treatments or who harbor the 17p deletion or TP53 mutation have limited options and typically a poor prognosis. Today's CHMP positive opinion marks a major step forward for these patients," said Michael Severino, M.D., executive vice president of research and development and chief scientific officer, AbbVie. "This innovation delivers on AbbVie's promise to develop cancer medicines where an unmet need exists. We will continue to work with European regulators to make venetoclax available to appropriate CLL patients."

CLL, a cancer of the bone marrow and blood, is typically a slow-progressing cancer. The 17p deletion – a genomic alteration in which a part of chromosome 17 is absent – is found in 3 to 10 percent of previously untreated CLL cases and up to 30 to 50 percent of relapsed or refractory CLL cases.1 A TP53 mutation occurs in 8 to 15 percent of patients at first-line treatment and up to 35 to 50 percent of cases in refractory CLL.1 Those with the 17p deletion or TP53 mutations often have a particularly poor prognosis1 and a median life expectancy of less than two to three years with current standard-of-care regimens.2

The positive CHMP opinion is a scientific recommendation for conditional marketing authorization to the European Commission. Review of the Marketing Authorization Application (MAA) is being conducted under the centralized licensing procedure. The European Medicines Agency (EMA) grants conditional marketing authorization to medicines in the interest of public health where the benefit of its immediate availability to patients outweighs the risk due to the need for additional data. If approved, the authorization will be valid in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.

About VENCLYXTO Orphan Drug Designations
Recently, the Committee for Orphan Medicinal Products (COMP) of the EMA adopted positive opinions on Orphan Drug Designation applications for VENCLYXTO for the treatment of multiple myeloma, a type of cancer that forms in plasma cells in bone marrow,3 and for diffuse large B-cell lymphoma (DLBCL), an aggressive type of lymphoma and the most common form of non-Hodgkin lymphoma (NHL).4 Previously, the EMA granted Orphan Drug Designation to VENCLYXTO for the treatment of CLL and for the treatment of acute myeloid leukaemia (AML), the most common type of acute leukaemia in adults.5

Orphan Drug Designation is granted to therapies aimed at the treatment, prevention or diagnosis of life-threatening diseases that affect no more than five in 10,000 persons in the European Union (EU) and for which no satisfactory therapy is available. The medicine must also provide significant benefit to those affected by the condition.6

About VENCLYXTO™ (venetoclax)
VENCLYXTO is an investigational oral B-cell lymphoma-2 (BCL-2) inhibitor being evaluated for the treatment of patients with various blood cancer types.7,8,9,10 The BCL-2 protein prevents apoptosis (programmed cell death) of some cells, including lymphocytes, and can be overexpressed in some cancer types. VENCLYXTO, which is given once daily, is designed to selectively inhibit the function of the BCL-2 protein.11

VENCLYXTO is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the U.S. and by AbbVie outside of the U.S. 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 chronic lymphocytic leukaemia (CLL), along with studies in several other cancers.

In April 2016, the U.S. Food and Drug Administration (FDA) granted accelerated approval of venetoclax tablets for the treatment of patients with CLL with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy.7 The FDA approved this indication under accelerated approval based on overall response rate, and continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.7

Venetoclax is under evaluation by health authorities in multiple countries, and is currently approved in Argentina, Puerto Rico and Canada. AbbVie, in collaboration with Roche and Genentech, is currently working with regulatory agencies around the world to bring this medicine to eligible patients in need.

About AbbVie in Oncology
AbbVie is striving to outsmart cancer by working with scientists, physicians, industry peers, patient advocacy groups and most importantly patients, to discover, develop and provide new therapies that will have a remarkable impact on the lives of people around the world affected by cancer. Our goal is to provide medicines that make a transformational improvement in cancer treatment and outcomes for cancer patients. By exploring and investing in new pathways, technologies and approaches, AbbVie is breaking ground in some of the most widespread and difficult-to-treat cancers. We are also exploring solutions to help patients obtain access to our cancer medicines. With the acquisition of Pharmacyclics in 2015 and Stemcentrx in 2016, and through several collaborations, AbbVie's oncology portfolio consists of marketed medicines and a pipeline containing multiple new molecules being evaluated worldwide in nearly 200 clinical trials in 20 different tumor types. For more information about AbbVie Oncology, please visit http://abbvieoncology.com.

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.

AbbVie 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 2015 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 Schnaiter A, et al. 17p deletion in chronic lymphocytic leukemia: risk stratification and therapeutic approach. Hematol Oncol Clin N Am. 2013; 27:289-301.
2 Stilgenbauer S, et al. Understanding and managing ultra high-risk chronic lymphocytic leukemia. Hematology Am Soc Hematol Educ Program. 2010; 1:481-488.
3 Multiple Myeloma Research Foundation. Learn the basics about multiple myeloma. https://www.themmrf.org/multiple-myeloma/. Accessed October 2016.
4 Lymphoma Research Foundation. Diffuse Large B-Cell Lymphoma (DLBCL). http://www.lymphoma.org/site/pp.asp?c=bkLTKaOQLmK8E&b=6300153. Accessed October 2016.
5 National Cancer Institute. Adult Acute Myeloid Leukemia Treatment (PDQ®)—Patient Version. Accessed October 2016. https://www.cancer.gov/types/leukemia/patient/adult-aml-treatment-pdq.
6 European Medicines Agency (2015). "Orphan Designation." http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000029.jsp. Accessed October 2016.
7 Clinicaltrials.gov. NCT01889186: A study of the efficacy of ABT-199 in subjects with relapsed or refractory chronic lymphocytic leukemia with the 17p deletion. Accessed August 2016.
8 Clinicaltrials.gov. NCT01994837: A Phase 2 Study of ABT-199 in subjects with Acute Myelogenous Leukemia (AML). Accessed August 2016.
9 Clinicaltrials.gov. NCT01794520: Study evaluating ABT-199 in subjects with relapsed or refractory Multiple Myeloma. Accessed August 2016.
10 Clinicaltrials.gov. NCT01328626: A Phase 1 study evaluating the safety and pharmacokinetics of ABT-199 in subjects with relapsed or refractory Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma. Accessed August 2016.
11 Davids M.S. and Letai A. ABT-199: A new hope for selective BCL-2 inhibition. Cancer Cell. 2013; 23(2): 139-141.