Roche’s Venclexta gets accelerated approval from US FDA for chronic lymphocytic leukemia

pharmafile | April 12, 2016 | News story | Manufacturing and Production, Research and Development, Sales and Marketing AbbVie, Roche, US FDA, Venclexta, chronic lymphocytic leukemia 

Swiss drug firm Roche (SIX: ROG) on Tuesday said the US Food and Drug Administration (FDA) has granted accelerated approval for its blood cancer drug. 

The company said a pivotal study showed clinically meaningful improvement in treating chronic lymphocytic leukemia (CLL) with its drug Venclexta (venetoclax). 

Chief Medical Officer, Sandra Horning, Roche, 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.” 

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, the company said. 

Venclexta is being jointly developed by US drugmaker AbbVie (NYSE: ABBV) and Roche. 

In the US, the drug will be jointly marketed by AbbVie and Roche’s arm Genentech, and by AbbVie outside of the US. 

Venclexta will be available to people in the US within about one week, Roche said in a statement.  

Venclexta was granted Breakthrough Therapy Designation by the FDA for the treatment of people with previously treated CLL with 17p deletion. Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases. 

CLL is the most common type of adult leukemia, and in 2016, there will be an estimated 4,660 deaths from the disease in the US. Although signs of CLL may disappear for a period of time after initial treatment, the disease is considered incurable and many people will require additional treatment due to the return of cancerous cells.  

Anjali Shukla

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