FDA grants full approval to Teva's Synribo

FDA granted full approval to Synribo omacetaxine mepesuccinate from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) to treat chronic or accelerated phase chronic myelogenous leukemia (CML) in adults with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKIs). FDA granted accelerated approval to Synribo in 2012 based on pooled response rate data from two open-label Phase II trials. The full approval was based on 24-month follow-up data from the trials. Teva gained the small molecule that targets the ribosome to inhibit synthesis of oncoproteins through its 2011 acquisition of Cephalon Inc. (see BioCentury Extra, Oct. 26, 2012). ...