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FDA Breakthrough Therapy: AbbVie’s Venetoclax For Chronic Lymphocytic Leukemia With 17p Deletion

May 6, 2015

AbbVie announces May 6th that the FDA grants the Breakthrough Therapy Designation (BTD) to its investigational oral non-orphan drug Venetoclax. The FDA BTD is for relapsed/refractory Chronic Lymphocytic Leukemia (CLL) with the 17p deletion genetic mutation. It is being developed in partnership with Genentech and Roche. Venetoclax is an inhibitor of the B-cell lymphoma-2 (BCL-2) protein.

According to AbbVie’s Press Release:

•   CLL accounts for about 25% of the new cases of leukemia diagnosed in the US

•   3 – 10% of CLL patients have the 17p deletion genetic mutation at diagnosis

•   30 – 50% of relapsed/refractory CLL patients have the 17p deletion genetic mutation

•   Median life expectancy for CLL patients with 17p deletion genetic mutation is < 2-3 years.

This is the 3rd BTD for AbbVie, and the 5th BTD for CLL. AbbVie plans on submitting regulatory applications for Venetoclax by the end of 2015, with both the FDA and the European Medicines Agency (EMA).



FDA BTD Approval Chart

FDA BTD Statistics Chart.

Please Note: “White Pocket Reflection” by John Fowler (Flickr: White Pocket Reflection) [CC BY 2.0] | Wikimedia Commons.

Copyright © 2012-2015, Orphan Druganaut Blog. All rights reserved.

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