Roche receives FDA grants for Venclexta

Roche announced that the U.S. FDA granted accelerated approval to Venclexta™ (venetoclax) for the treatment of people with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy.

The pivotal study showed a clinically meaningful improvement (overall response rate, ORR) in 80.2 percent of people (95 percent CI 71.3-87.3). Venclexta is the first approved medicine designed to help restore a process in which cells self-destruct (apoptosis) by selectively blocking the BCL-2 protein and is Roche’s tenth new medicine approved in the past seven years. Venclexta is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the United States and commercialised by AbbVie outside of the United States.

Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development said,Up to half of people whose CLL progressed have 17p deletion, a genetic marker that makes the disease difficult-to-treat.Venclexta is the first approved medicine designed to trigger a natural process that helps cells self-destruct, and is a new way to help people who have been previously treated and have this high-risk form of the disease.