UPDATE 1-FDA approves Teva leukemia drug


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.