Teva Pharmaceutical Industries Ltd. TEVA announced today that the U.S.
Food and Drug Administration (FDA) approved SYNRIBO (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.”
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