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FDA Approves Teva Pharmaceutical Industries Ltd Leukemia Drug-Reuters


Friday, 26 Oct 2012 11:49am EDT 

Reuters reported that the U.S. Food and Drug Administration on October 26, 2012 said it has approved a new leukemia treatment from Teva Pharmaceutical Industries Ltd to be sold under the brand name Synribo. The drug, also known as omacetaxine mepesuccinate, is approved to treat a type of the blood and bone marrow cancer called chronic myelogenous leukemia, or CML, in patients whose cancer has progressed after treatment with at least two drugs from a class called tyrosine kinase inhibitors. Synribo, which is injected under the skin twice daily for 14 consecutive days over a 28-day cycle until white blood cell counts normalize, works by blocking proteins that help the development of cancerous cells. Synribo received an accelerated approval based on the disease response to the drug in studies. However it has yet to demonstrate an improvement in disease symptoms or an increased survival benefit in a clinical trial, the FDA and company said.