FDA grants venetoclax NDA status for leukaemia treatment

The US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and granted Priority Review for Genentech’s venetoclax for the treatment of chronic lymphocytic leukaemia (CLL)

Venetoclax has been given FDA NDA status for the treatment of people with CLL who have received at least one prior therapy, including those with 17p deletion.

Venetoclax is a small molecule inhibitor of the BCL-2 protein being developed in partnership with AbbVie and was granted Breakthrough Therapy Designation by the FDA in April 2015 for the treatment of people with previously treated (relapsed or refractory) CLL with 17p deletion.

Sandra Horning, chief medical officer and head of global product development, Genentech, said: "Venetoclax is a potential new way to treat this difficult type of chronic lymphocytic leukaemia.

“We look forward to working with AbbVie and health authorities to bring this first-of-its-kind medicine to people who need more options."

A Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.

Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases and to help ensure people have access to them through FDA approval as soon as possible.

The NDA for venetoclax is based in part on data from the pivotal Phase two M13-982 study.

 A Marketing Authorisation Application for venetoclax has also been validated by the European Medicines Agency.