FDA approves Teva leukemia drug
Israel-based generic drug maker gets approval for treatment for type of blood, bone marrow cancer called CML
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.
"Today's approval provides a new treatment option for patients who are resistant to or cannot tolerate other FDA-approved drugs for chronic or accelerated phases of CML," Richard Pazdur, director of the Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation and Research, said in a statement.
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.
It is the second CML drug approved by the FDA in recent weeks after the September approval of Pfizer Inc's Bosulif.
An estimated 5,430 Americans will be diagnosed with CML in 2012, according to the National Institutes of Health.
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.
Israel-based Teva, the world's largest generic drug maker, has advanced its focus on developing new medicines, in part through its acquisition of the US biotech Cephalon.
