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Synribo, Omacetaxine mepesuccinate (formerly Ceflatonin, Omapro)

Also known as: sHHT (formerly CGX-635, homoharringtonine)

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Company Teva Pharmaceutical Industries Ltd.
DescriptionSmall molecule that targets the ribosome to inhibit synthesis of oncoproteins
Molecular Target Cyclin D1 (CCND1) (BCL1) ; Myeloid leukemia cell differentiation protein (MCL1)
Mechanism of ActionMyeloid leukemia cell differentiation protein (Mcl-1) inhibitor
Therapeutic ModalitySmall molecule
Latest Stage of DevelopmentMarketed
Standard IndicationChronic myelogenous leukemia (CML)
Indication DetailsTreat chronic myelogenous leukemia (CML) patients who are resistant to Gleevec or other tyrosine kinase inhibitors; Treat chronic myelogenous leukemia (CML) patients who have failed prior treatment with 2 or more tyrosine kinase inhibitors (TKIs), regardless of their mutation status; Treat chronic or accelerated phase chronic myelogenous leukemia in patients who have resistance and/or intolerance to >=2 tyrosine kinase inhibitors; Treat chronic, accelerated and blast-phase chronic myelogenous leukemia (CML) in Gleevec-resistant patients with the BCR-ABL T315I mutation; Treat Gleevec-resistant chronic myelogenous leukemia (CML); Treat Gleevec-resistant chronic myelogenous leukemia (CML) in patients with the BCR-ABL T315I mutation; Treat Gleevec-resistant chronic myelogenous leukemia (CML) patients with the BCR-ABL T315I mutation
Regulatory Designation

U.S. - Accelerated Approval (Treat chronic or accelerated phase chronic myelogenous leukemia in patients who have resistance and/or intolerance to >=2 tyrosine kinase inhibitors);
U.S. - Priority Review (Treat chronic, accelerated and blast-phase chronic myelogenous leukemia (CML) in Gleevec-resistant patients with the BCR-ABL T315I mutation)

Partner

Hospira Inc.


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