Roche/AbbVie granted Breakthrough Therapy designation by FDA for venetoclax

Swiss pharma major Roche (ROG: SIX) has been granted Breakthrough Therapy designation by the US Food and Drug Administration for its investigational medicine venetoclax. The drug is being developed with US pharma company AbbVie (NYSE: ABBV).

The therapy has received the designation for treatment of chronic lymphocytic leukemia in previously-treated patients with the 17p deletion genetic mutation. Approximately 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 to three years.

"We are pleased that the FDA has granted venetoclax breakthrough therapy designation and hope this regulatory pathway will help us bring venetoclax to people with this difficult-to-treat disease soon," Roche chief medical officer and head of global clinical development Sandra Horning