US FDA approves AbbVie and Roche's CLL drug Venclexta

The US Food and Drug Administration on Monday granted accelerated approval for US drugmaker AbbVie’s (NYSE: ABBV) Venclexta (venetoclax) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have a chromosomal abnormality called 17p deletion and who have been treated with at least one prior therapy.

Venclexta, which has been developed in cooperation with Swiss pharma giant Roche (ROG: SIX) and its subsidiary Genentech, is the first FDA-approved treatment that targets the B-cell lymphoma 2 (BCL-2) protein, which supports cancer cell growth and is over-expressed in many patients with CLL.

Venclexta will be available to people in the USA within about one week, said Genentech and AbbVie in their separate press releases. For those who qualify, Genentech and AbbVie plan to offer patient assistance programs for people taking Venclexta.