Swiss drugmaker Roche said on Thursday the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation for venetoclax for the treatment of people who have relapsed or refractory chronic lymphocytic leukemia with a genetic abnormality.
"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 said in a statement.
Breakthrough therapy designation is given when early data shows a product may confer substantial improvement over existing therapies.
© 2023 Thomson/Reuters. All rights reserved.