Teva’s chronic myelogenous leukemia drug approved by US FDA

Hannah Blake

pharmaphorum

Teva Pharmaceuticals has announced that the US FDA has approved its drug, Synribo (omacetaxine mepesuccinate), for injection to treat adults with chronic phase or accelerated phase chronic myelogenous leukemia (CML) with resistance and / or intolerance to two or more tyrosine kinase inhibitors (TKIs).

CML is a cancer of the blood and bone marrow. According to the National Institutes of Health, an estimated 5,430 people will be diagnosed with CML in 2012. Synribo is intended to be used in patients whose cancer progressed after treatment with at least two drugs from a class called tyrosine kinase inhibitors (TKIs), also used to treat CML.

The FDA’s approval of Synribo was based on an analysis of combined data subsets from two Phase 2 clinical trials. The pooled analysis included patients who had received two or more approved TKIs and, at a minimum, had evidence of resitance or intolerance to dasatinib and / or nilotinib.

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

In accelerated phase CML, results showed five out of 35 patients (14.3%) achieved major hemotologic response (MaHR) / normalization of white blood cell counts in an average time of 2.3 months. The median duration of MaHR in these patients was 4.7 months.

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

Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research (26th October 2012).

Teva’s Synribo is the second drug to be approved by the FDA for treatment of patients with CML in the United States in the last few months. In September 2012, the FDA approved Pfizer’s Bosulif (bosutinib) to treat patients with chronic, accelerated or blast phase Philadelphia chromosome positive CML who are resistant to or who cannot tolerate other therapies.

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