Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) approved
(omacetaxine mepesuccinate) for Injection to treat adult patients with chronic phase (CP) or accelerated phase (AP) chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKIs). The indication is based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with SYNRIBO. It will be available for prescribing shortly.
Previously, CP and AP CML patients who failed on two or more TKIs have had limited treatment options. “While the CML treatment landscape has seen advancements with available TKI treatments, there are still cases where patients may not be able to continue using TKIs due to issues such as resistance, intolerance, suboptimal response, and disease progression,” said Jorge E. Cortes, M.D., deputy chair and professor of medicine in the Department of Leukemia at The University of Texas MD Anderson Cancer Center. “With SYNRIBO, physicians will now have access to another option, offering potential hope to patients who experience treatment failure.”
SYNRIBO received an accelerated approval that allows the FDA to approve a drug to treat a serious disease based on clinical data showing that the drug has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients. The program is designed to provide patients with earlier access to promising new drugs. Full approval is expected following submission of more mature data from pivotal analysis.
“Teva Pharmaceuticals is pleased to bring SYNRIBO to the market for patients who need additional treatment options when others have failed,” said Michael R. Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer of Teva Pharmaceutical Industries Ltd. “SYNRIBO joins TREANDA and TRISENOX as important hematologic treatment options in the Teva Oncology portfolio.”