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Synribo Approved by FDA for Chronic Myelogenous Leukemia

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According to the National Institutes of Health, approximately 5430 people will be diagnosed with chronic myelogenous leukemia in 2012

Synribo (omacetaxine mepesuccinate) was recently approved by the FDA to treat adults with chronic myelogenous leukemia (CML) whose cancer has progressed after treatment with at least 2 tyrosine kinase inhibitors (TKIs).

Certain proteins that promote the development of cancerous cells are blocked by omacetaxine mepesuccinate. It is injected subcutaneously twice daily for 14 consecutive days over a 28-day cycle until white blood cell counts normalize. Then, as long as patients continue to clinically benefit from therapy, omacetaxine mepesuccinate is administered twice daily for 7 consecutive days over a 28-day cycle.

“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.

Researchers evaluated the effectiveness of omacetaxine mepesuccinate in a study involving patients whose cancer progressed after previous treatment with 2 or more TKIs. All participants were treated with omacetaxine mepesuccinate.

In chronic-phase CML, the drug’s effectiveness was demonstrated by a decrease in the percentage of cells expressing the Philadelphia chromosome genetic mutation found in most CML patients. Among 76 patients, 14 (18.4%) achieved a reduction in an average time of 3.5 months. The median length of the reduction was 12.5 months.

The effectiveness of omacetaxine mepesuccinate in accelerated-phase CML was established by the number of patients who experienced a normalization of white blood cell counts or had no evidence of leukemia (major hematologic response, MaHR). Of 35 patients, 5 (14.3%) achieved MaHR in an average time of 2.3 months. The median duration of MaHR in these patients was 4.7 months.

The most common side effects reported during clinical studies include thrombocytopenia, anemia, neutropenia that may lead to febrile neutropenia, diarrhea, nausea, weakness and fatigue, injection site reaction, and lymphopenia.

Source: FDA.