AbbVie’s investigational drug venetoclax has been assigned breakthrough status in the US as a treatment for chronic lymphocytic leukaemia in patients who carry a specific genetic mutation known as 17p deletion.
Around 3%-10% of CLL patients have 17p deletion at diagnosis, and it occurs in 30%-50% of patients with relapsed/refractory CLL. The median life expectancy for CLL patients with 17p deletion is less than two-three years, highlighting the urgent need for new, effective therapies to improve the outlook.
Breakthrough Therapy Designation for venetoclax, which is being developed in partnership with Genentech and Roche, indicates that US officials believe it potentially offers substantial improvement on existing therapies.
The drug is currently being assessed in Phase II and III trials for the treatment of CLL, along with studies in several other cancers.