Oct 26 (Reuters) - The U.S. Food and Drug Administration on
Friday 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.
"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
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 drugmaker,
has advanced its focus on developing new medicines, in part
through its acquisition of the U.S. biotech Cephalon.