FDA Grants Full Approval to Synribo (Omacetaxine Mepesuccinate) for Chronic Myeloid Leukemia
The FDA granted full approval on Thursday for Synribo (omacetaxine mepesuccinate), according to a news release from Teva Pharmaceuticals, the drug's manufacturer. The injectable drug was initially approved under the FDA's accelerated approval process in October 2012 to treat patients with chronic myeloid leukemia (CML) who have failed treatment with 2 or more tyrosine kinase inhibitors.
The full approval was based on results of two, phase 2, open-label, multicenter trials. A major cytogenetic response was found in 18% of patients with chronic phase CML, and the mean time to onset was 3.5 months. A major hematologic response was found in 14% of patients with accelerated phase CML, and the mean time to onset was 2.3 months. The following adverse reactions were found in at least 20% of patients: thrombocytopenia, anemia, neutropenia, diarrhea, nausea, fatigue, asthenia, injection site reaction, pyrexia, infection, and lymphopenia.
Patients who are prescribed omacetaxine mepesuccinate inject the drug subcutaneously twice daily for 14 consecutive days of a 28-day cycle until they have a hematologic response. They then take the drug twice daily for 7 consecutive days of a 28-day cycle as long as they have a clinically beneficial response.
According to the news release, the American Cancer Society estimates there will be 5980 new cases of CML diagnosed in the United States in 2014 and 810 deaths related to the disease. The Leukemia & Lymphoma Society estimates 26,359 people in the United States have CML.
