AbbVie’s venetoclax will be reviewed by both US and EU regulators as a potential first-in-class treatment for certain adults with chronic lymphocytic leukaemia.
The US Food and Drug Administration has assigned the drug 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 associated with a poor patient prognosis.
In Europe it is being assessed under a normal timeframe as a treatment for patients carrying either the 17p deletion or TP53 mutations.
Venetoclax is an inhibitor of the B-cell lymphoma-2 (BCL-2) protein - developed in partnership with Genentech and Roche to treat CLL - which is thought to work by leading some cells to undergo cell death.
The filings are supported by data from a Phase II data study which AbbVie says met its primary endpoint of achieving an overall response rate, with no unexpected safety signals.
Analysts at Brokerage Cowen and Co predict that venetoclax could generate annual sales of $2 billion by 2020, if it gets approved, reports Reuters.