FDA and EMA accept filing of venetoclax for the treatment of chronic lymphocytic leukemia (CLL) - AbbVie

AbbVie announced that the FDA has accepted AbbVie's New Drug Application (NDA) granting priority review for venetoclax for the treatment of chronic lymphocytic leukemia (CLL) in adults who have received at least one prior therapy, including patients with 17p deletion. With priority review, the FDA's goals include a faster timeline for review of six months, compared to 10 months for the standard review period.

Additionally, AbbVie announced the European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) for venetoclax for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion or TP53 mutation. Venetoclax is an inhibitor of the B-cell lymphoma-2 (BCL-2) protein being developed in partnership with Genentech and Roche to treat CLL. Venetoclax is believed to lead some cells, including some cells with CLL, to undergo apoptosis, or cell death.

Comment:The NDA and MAA are supported by pivotal data from a Phase II, open-label study of venetoclax in patients with relapsed/refractory CLL with 17p deletion, a genetic variation in CLL associated with a poor patient prognosis. In August 2015, AbbVie announced the Phase II study met its primary endpoint of achieving an overall response rate, according to an assessment by an independent review committee.