What is the role of protein translation inhibitors in the treatment of chronic myelogenous leukemia (CML)?

Updated: May 23, 2021
  • Author: Emmanuel C Besa, MD; Chief Editor: Sara J Grethlein, MD, FACP  more...
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Answer

In October 2012, the US Food and Drug Administration (FDA) approved omacetaxine (Synribo). Omacetaxine is a protein translation inhibitor that is indicated for chronic- or accelerated-phase CML with resistance and/or intolerance to 2 or more tyrosine kinase inhibitors (TKIs) (eg, dasatinib, nilotinib, imatinib).

Approval was based on combined data from 2 phase 2, open-label, multicenter studies. Pooled data included patients (n=111) who had received two or more TKIs and showed evidence of resistance or intolerance. In patients with chronic-phase CML taking omacetaxine, 18% attained a major cytogenetic response (MCyR) (mean time to MCyR onset, 3.5 mo). The median duration of MCyR was 12.5 months. Of patients with accelerated-phase CML who received omacetaxine, 14% attained a major hematologic response (MaHR); mean time to MaHR was 2.3 mo and mean duration of MaHR was 4.7 months. [59]


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