US FDA grants breakthrough therapy designation for investigational Bcl-2 inhibitor venetoclax in 17p deletion relapsed-refractory chronic lymphocytic leukemia

Industry News

The U.S. Food and Drug Administration has granted venetoclax (RG7601, GDC-0199/ABT-199) Breakthrough Therapy Designation for the treatment of chronic lymphocytic leukemia (CLL) in previously treated (relapsed/refractory) patients with the 17p deletion genetic mutation.  Venetoclax is an investigational medicine being developed by AbbVie (based in North Chicago, IL USA) in partnership with Roche (a global pharmaceutical and diagnostic company headquartered in Basel, Switzerland).  Venetoclax is an orally bioavailable and selective inhibitor of Bcl-2, a protein involved in programmed cell death, and often over-expressed in CLL and other types of B-cell related cancers.  CLL is a slow-progressing cancer of the bone marrow and blood, representing about 25% of newly diagnosed leukemia.  Chromosomal 17p deletion accounts for 30-50% of relapsed/refractory CLL.  Ventoclax addresses an unmet medical need and is currently being evaluated in Phase II and Phase III studies for CLL and in Phase I and II studies for several other blood cancers.

 

References:

http://abbvie.mediaroom.com/2015-05-06-Investigational-Medicine-Venetoclax-Receives-Breakthrough-Therapy-Designation-in-Relapsed-or-Refractory-Chronic-Lymphocytic-Leukemia-in-Previously-Treated-Patients-with-the-17p-Deletion-Genetic-Mutation
http://www.roche.com/investors/updates/inv-update-2015-05-07.htm

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