The Food and Drug Administration of the United States have approved breakthrough therapy designation to a Swiss drug manufacturer, Roche Holding AG (RO.EB) for leukemia drug, venetoclax for accelerating the regulatory review process for the therapy.
Roche, the Basel-based company has announced on Thursday that the FDA has given the expedited review to venetoclax that is being tested for treating a type of chronic lymphocytic leukemia with a genetic abnormality that is called 17p deletion. Venetoclax has been developed by Roche partnering with AbbVie Inc. ABBV, -0.39% is also testing this drug for numerous other blood cancers.
Roche Chief Medical Officer and Head of Global Clinical Development Sandra Horning said in a statement, “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.”
Chronic lymphocytic leukemia is a slow-growing cancer of the blood and bone marrow that is considered as a terminal disease and it is one of the most widespread forms of the disease that has been affecting adults all across the globe.
The FDA grants breakthrough therapy designation only to drugs which intends to treat life-threatening conditions. It is only granted when clinical evidence indicates that a drug has the possibility of demonstrating significant improvement over the existing therapies implemented. This designation will be speeding up its FDA development and review.