Venetoclax is the new medicine developed by Roche in partnership with AbbVie Inc. that can be a cure for Chronic Lymphocytic Leukemia (CLL). Thursday, the company announced that the US Food and Drug Administration gave Venetoclax the expedited review.
The new medicine arrives on the market when conventional treatments for CLL patients are scarce and usually yield poor results, leaving the patients with a reported life expectancy of two to three years.
CLL is a cancer of the blood and bone marrow that in the majority of cases manifests itself in the white blood cells (B-cells). Some cases of CLL present a loss of chromosome 17, thus forming a category of CLL known as 17p deletion Chronic Lymphocytic Leukemia. For patients suffering of this form of CLL, the chances of curing are typically slim. CLL is considered a terminal disease and is affecting adults all across the globe.
In the United States, out of Leukemia diagnosed cases, approximately one quarter are diagnosed as CLL. Within that quarter, 3 to 10 percent of new cases and 30 to 50 percent of relapsed cases present the 17p deletion.
Following the FDA’s release of the expedited review, Sandra Horning, Roche Chief Medical Officer, as well as Head of Global Clinical Development stated:
“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.”
The results of previous trials of Venetoclax were presented at the 56th Annual Meeting and Exposition of the American Society of Hematology.
With the FDA approving breakthrough therapy designation it is expected that Venetoclax will soon be available on the market on completion of clinical trials. At the moment, Venetoclax is studied in relation to Phase II and III for CLL and Phase I and Phase II for other blood cancers.
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