Teva Pharmaceutical Industries Ltd. (TEVA) said the U.S. Food and Drug Administration or FDA has granted full approval of SYNRIBO for injection. This oncology portfolio product received an accelerated approval in October, 2012 with additional study data required to fulfill post marketing requirements set forth by the FDA.
SYNRIBO is indicated for adult patients with chronic phase or accelerated phase chronic myeloid leukemia or CML with resistance and/or intolerance to two or more tyrosine kinase inhibitors or TKIs. SYNRIBO, which was originally granted an accelerated approval by the FDA in October 2012, is the first protein synthesis inhibitor for CML.
Rob Koremans, M.D., President and CEO, Global Specialty Medicines, said: "With this approval, based on the final analysis of two Phase II trials that evaluated efficacy and tolerability data of SYNRIBO®, we believe healthcare providers can be even more confident in the clinical profile of this important medicine."
Chronic myeloid leukemia, also known as chronic myelogenous leukemia, is one of four main types of leukemia and is a cancer of the blood and bone marrow.
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