AbbVie Leukemia Drug Under Review
Venetoclax, a novel leukemia treatment developed by biopharmaceutical company AbbVie, is to be reviewed by regulators in the US and EU. The drug is described as a potential first-in-class therapy for certain adults with chronic lymphocytic leukemia (CLL). The slow-progressing cancer of the bone marrow and blood and is the most common leukemia diagnosed in adults in western countries.
In the US, the Food and Drug Administration (FDA) has granted venetoclax a priority review for use in patients who have received at least one prior therapy, including those with 17p deletion, a genetic variation in CLL that carries a poor prognosis. With priority review, the FDA’s goal is for a review of six months compared with the standard 10-month period.
In Europe, a marketing authorization application for the drug has been validated for treating patients carrying either the 17p deletion or TP53 mutation.
Developed in collaboration with Genentech and Roche, venetoclax is an inhibitor of the B-cell lymphoma-2 (BCL-2) protein. It is believed to lead some cells, including some cells with CLL, to undergo apoptosis, or cell death.
The filings are supported by the results of a Phase II study which AbbVie said met its primary target of achieving an overall response rate with no unexpected safety signals.
Analysts told the news agency Reuters that venetoclax could generate annual sales of $2 billion by 2020.