FDA grants accelerated approval for Synribo ( Cephalon/Teva) for CML - 28-Oct-2012

The FDA on 26 October 2012 granted accelerated approval for Synribo (omacetaxine mepesuccinate)from Cephalon/Teva to treat adults with Chronic Myelogenous Leukemia (CML), a blood and bone marrow disease.

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 percent) 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, Synribo’s effectiveness was determined by the number of patients who experienced a normalization of white blood cell counts or had no evidence of leukemia (major hematologic response, or MaHR). Results showed five out of 35 patients (14.3 percent) achieved MaHR in an average time of 2.3 months. The median duration of MaHR in these patients was 4.7 months.

Rights to omacetaxine mepesuccinate, known as Omapro, in Europe are held by Hospira and the filing has been temporarily withdrawn from EMA.