New Chronic Leukemia Drug Approved

Synribo approved for chronic myelogenous leukemia

(RxWiki News) A new medication for chronic myelogenous leukemia (CML) has been approved by the US Food and Drug Administration.

Synribo (omacetaxine mepesuccinate) is now available to treat people whose disease has gotten worse after being treated with at least two other currently available medications called tyrosine kinase inhibitors (TKIs).

Synribo works by blocking proteins that encourage the development and growth of cancer cells.

“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,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research.

“Synribo is the second drug approved to treat CML in the past two months.”

In September, the FDA approved Bosulif (bosutinib) to treat Philadelphia chromosome positive CML for patients who are resistant to or can't tolerate other therapies.

The FDA also just granted an accelerated review of ponatinib for Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL), which will be acted upon by March 2013. Synribo was also approved under the same program.

CML will be diagnosed in the nearly 5,500 people in the United States this year, according to the National Institutes of Health.

Synribo is marketed by Teva Pharmaceuticals. Bosulif is marketed by Pfizer. Ponatinib is a product of Ariad Pharmaceuticals.

Review Date: 
October 26, 2012