FDA, EMA Advance AbbVie’s Leukemia Drug
The US Food and Drug Administration (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 reports the European Medicines Agency has validated its marketing authorization application (MAA) for venetoclax for the treatment of patients with 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.
The FDA previously granted venetoclax breakthrough therapy designation (BTD) in April 2015 for the treatment of CLL in previously treated patients with the 17p deletion genetic mutation.