FDA Approves New Treatment Option for Hard-To-Treat Type of Chronic Lymphocytic Leukemia
April 11th, 2016
On April 11, 2016, the FDA granted accelerated approval to VenclextaTM (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 indication for Venclexta is approved under accelerated approval based on overall response rate (ORR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
News in brief
- Accelerated approval allows conditional approval of a medicine that fills an unmet medical need for a serious condition based on early evidence suggesting clinical benefit
- The pivotal M13-982 study of Venclexta in people with previously treated 17p deletion CLL showed a clinically meaningful improvement (ORR) in 80 percent of participants
- Venclexta is the first medicine of its kind approved by the FDA, and Genentech’s tenth new medicine approved in the past seven years
Supporting Information
“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.”