On October 14, 2016 AbbVie (NYSE: ABBV), a global biopharmaceutical company, reported 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 (Press release, AbbVie, OCT 14, 2016, View Source [SID:SID1234515804]). 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.

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"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.