Venetoclax Receives FDA Breakthrough Designation for CLL

An investigational chronic lymphocytic leukemia (CLL) treatment known as venetoclax has been granted Breakthrough Therapy Designation from the FDA.

AbbVie, Roche, and Genentech are collectively developing the oral B-cell lymphoma-2 inhibitor to treat relapsed or refractory CLL patients with the 17p deletion genetic mutation.

About 3% to 10% of CLL patients are diagnosed with this abnormality, and it occurs in 30% to 50% of those with previously treated CLL. These patients have a median life expectancy of less than 2 to 3 years.

“People who have relapsed or refractory CLL with a 17p deletion typically have a poor prognosis, and do not respond to many currently available treatment options,” said Sandra Horning, MD, Roche’s chief medical officer and head of global clinical development, in a press release. “We are pleased that the FDA has granted venetoclax Breakthrough Therapy designation and hope this regulatory pathway will help us bring venetoclax to people with this difficult-to-treat disease soon."

Venetoclax is currently being studied in several blood cancers, including CLL.