The U.S. Food and Drug Administration has granted breakthrough therapy designation to venetoclax for use in combination with rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL). Venetoclax is an inhibitor of the B-cell lymphoma-2 protein.
The breakthrough therapy designation, enacted as part of the FDA's 2012 Safety and Innovation Act, was created to expedite the development and review time of a potential new drug for serious or life-threatening disease where early clinical evidence suggests the drug may demonstrate substantial improvement compared with existing therapies.
A Phase III clinical trial for venetoclax in combination with rituximab is currently ongoing in patients with relapsed or refractory CLL. Venetoclax had previously received breakthrough therapy designation from the FDA for the treatment of patients with relapsed or refractory CLL with the 17p deletion genetic mutation (OT 6/25/15 issue).
Venetoclax is being developed by AbbVie in partnership with Genentech and Roche.