FDA approves Teva's Synribo for blood and bone marrow cancer

Agency decision marks second drug approval in two months for chronic myelogenous leukemia

SILVER SPRING, Md. — The Food and Drug Administration has approved what it called the second new drug in two months for a form of leukemia, the agency said Friday.

The FDA announced the approval of Teva Pharmaceutical Industries' Synribo (omacetaxine mepesuccinate) for chronic myelogenous leukemia, or CML, a disease that the National Institutes of Health expects will be diagnosed in more than 5,400 people this year. The drug is intended for patients whose disease has progressed after treatment with at least two drugs of a class used to treat the disease.

"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," FDA Office of Hematology and Ongology Products director Richard Pazdur said.

The drug is the second one approved for CML in two months. Last month, the agency approved Pfizer's Bosulif (bosutinib) for patients for chronic, accelerated or blast-phase Philadelphia chromosome-positive CML who are resistant to or can't tolerate other therapies.

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