FDA approves Teva's Synribo

FDA granted accelerated approval to an NDA from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) for Synribo omacetaxine mepesuccinate to treat chronic or accelerated phase chronic myelogenous leukemia (CML) in patients who have resistance and/or intolerance to two or more tyrosine kinase inhibitors. Teva said it will launch Synribo in the next three weeks. FDA based the approval on pooled response rate data from two open-label Phase II trials. In 76 chronic phase patients, 18% achieved a major cytogenetic response for a median duration of 12.5 months. Mean time to response onset was 3.5 months. In 35 accelerated phase patients, 14% achieved a major hematologic response for a median duration of 4.7 months. Mean time to response onset was 2.3 months.

Teva will be required to provide FDA with 24-month data from the Phase II studies, which the company expects to submit in early 2013. Teva will also conduct postmarketing studies, but did not provide details. FDA has not yet posted Synribo's approval letter. Teva gained the product through last year's acquisition of Cephalon Inc. Synribo is a small molecule that targets the ribosome to inhibit synthesis of oncoproteins. ...