AbbVie announced that the U.S. Food and Drug
Administration (FDA) 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.
The FDA granted venetoclax Breakthrough Therapy Designation (BTD) in April 2015
for the treatment of CLL in previously treated patients with the 17p
deletion genetic mutation, underscoring the potential for venetoclax to
provide substantial improvement over current therapies in this difficult
to treat patient population.
