AbbVie, a research-based biopharmaceutical company, has been granted breakthrough therapy designation to Venetoclax by the US FDA for the treatment of chronic lymphocytic leukemia (CLL) in previously treated (relapsed/refractory) patients with the 17p deletion genetic mutation.
Chronic lymphocytic leukemia (chronic lymphoid leukemia, CLL) is a monoclonal disorder characterized by a progressive accumulation of functionally incompetent lymphocytes (see the image below). It is the most common form of leukemia found in adults in Western countries.Some patients die rapidly, within 2-3 years of diagnosis, because of complications from CLL, but most patients live 5-10 years.
According to the FDA, breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. A breakthrough therapy designation conveys all of the fast track programme features, as well as more intensive FDA guidance on an efficient drug development programme.
Venetoclax is an investigational oral B-cell lymphoma-2 (BCL-2) inhibitor being evaluated for the treatment of patients with various cancer types. The BCL-2 protein stop apoptosis of some cells, including lymphocytes, and can be expressed in some cancer types. Venetoclax inhibit the function of the BCL-2 protein. Venetoclax is being developed in collaboration with Genentech and Roche.
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