FDA Approves Israeli Leukemia Drug

By Reuters

Published October 26, 2012.
  • Print
  • Share Share

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.


The Jewish Daily 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 Jewish Daily Forwardrequires 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. 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 Jewish Daily Forward reserves the right to remove comments for any reason.





Find us on Facebook!
  • Happy birthday Barbra Streisand! Our favorite Funny Girl turns 72 today.
  • Clueless parenting advice from the star of "Clueless."
  • Why won't the city give an answer?
  • BREAKING NEWS: Israel has officially suspended peace talks with the Palestinians.
  • Can you guess what the most boring job in the army is?
  • What the foolish rabbi of Chelm teaches us about Israel and the Palestinian unity deal:
  • Mazel tov to Idina Menzel on making Variety "Power of Women" cover! http://jd.fo/f3Mms
  • "How much should I expect him and/or ask him to participate? Is it enough to have one parent reciting the prayers and observing the holidays?" What do you think?
  • New York and Montreal have been at odds for far too long. Stop the bagel wars, sign our bagel peace treaty!
  • Really, can you blame them?
  • “How I Stopped Hating Women of the Wall and Started Talking to My Mother.” Will you see it?
  • Taglit-Birthright Israel is redefining who they consider "Jewish" after a 17% drop in registration from 2011-2013. Is the "propaganda tag" keeping young people away?
  • Happy birthday William Shakespeare! Turns out, the Bard knew quite a bit about Jews.
  • Would you get to know racists on a first-name basis if you thought it might help you prevent them from going on rampages, like the recent shooting in Kansas City?
  • "You wouldn’t send someone for a math test without teaching them math." Why is sex ed still so taboo among religious Jews?
  • from-cache

Would you like to receive updates about new stories?




















We will not share your e-mail address or other personal information.

Already subscribed? Manage your subscription.