The Food and Drug Administration has granted breakthrough therapy designation to venetoclax for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) with the 17p deletion genetic mutation. Venetoclax is an inhibitor of the B-cell lymphoma protein.
The 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.
Approximately three to 10 percent of patients with CLL have the 17p deletion at diagnosis, and it occurs in 30 to 50 percent of patients with relapsed or refractory CLL, notes a news release from the drug's manufacturer, AbbVie, which is collaborating with Genentech and Roche to develop the drug.
Venetoclax is currently being evaluated in Phase II and III clinical trials for this indication.