FDA Approves Israeli Leukemia Drug

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 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 drugmaker, has advanced its focus on developing new medicines, in part through its acquisition of the U.S. biotech Cephalon.

Tagged as:

Written by


Your Comments

The Forward welcomes reader comments in order to promote thoughtful discussion on issues of importance to the Jewish community. In the interest of maintaining a civil forum, The Forward requires that all commenters be appropriately respectful toward our writers, other commenters and the subjects of the articles. Vigorous debate and reasoned critique are welcome; name-calling and personal invective are not and will be deleted. Egregious commenters will be banned from commenting. While we generally do not seek to edit or actively moderate comments, our spam filter prevents most links and certain key words from being posted and the Forward reserves the right to remove comments for any reason.

Recommend this article

FDA Approves Israeli Leukemia Drug

Thank you!

This article has been sent!