Venclexta venetoclax regulatory update

FDA granted accelerated approval to an NDA from AbbVie for Venclexta venetoclax to treat chronic lymphocytic leukemia (CLL) in patients with the 17p deletion who have received >=1 prior therapy. Roche’s Genentech unit and AbbVie plan to launch the drug “within a week” of the April 11 approval and said an annual supply will cost about $109,500. The small molecule B cell lymphoma 2 ( BCL-2; BCL2) inhibitor has breakthrough therapy designation for the indication. FDA said Venclexta is the first therapy it has approved that targets BCL-2. ...