FDA Awards Breakthrough Therapy Designation to Venetoclax
The FDA has granted breakthrough therapy designation to AbbVie’s venetoclax to treat relapsed or refractory chronic lymphocytic leukemia in people with a certain genetic abnormality — paving the way for its speedy development and review.
Venetoclax (RG7601, GDC-0199/ABT-199), an investigational B-cell lymphoma-2 protein inhibitor, received the designation for patients with 17p deletion, which is found in 3 percent to 10 percent of previously untreated cases and 30 percent to 50 percent of relapsed or refractory cases, AbbVie said Wednesday.
The drug is being evaluated in Phase II and III studies for CLL, and in Phase I and II trials for several other blood cancers.
AbbVie — which is developing venetoclax in collaboration with Genentech in the U.S. and Roche outside the U.S. — plans to submit regulatory applications to the FDA and the European Medicines Agency before the end of the year.
People who have relapsed or refractory CLL with a 17p deletion typically have a poor prognosis and poor response to currently available treatment options, the drugmaker says. — Jonathon Shacat