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