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Omacetaxine (Synribo) is a twice-daily injection under the skin for chronic myeloid leukaemia that has stopped responding to at least two tyrosine kinase inhibitor pills.
Omacetaxine mepesuccinate, a semi-synthetic form of the plant alkaloid homoharringtonine, was granted accelerated approval by the FDA in October 2012, converted to full approval in 2014, for chronic or accelerated phase CML with resistance or intolerance to two or more tyrosine kinase inhibitors, on pooled phase 2 studies in which a minority of heavily pretreated patients achieved major cytogenetic responses, including those with the T315I mutation. Because it does not act on the kinase, it retains activity against any BCR-ABL mutation, but asciminib and ponatinib have narrowed its role. Myelosuppression is the main toxicity, and it has not been authorised in the EU.
Binds the A-site cleft of the ribosome and blocks the elongation step of protein synthesis; reduces short-lived oncoproteins such as BCR-ABL and MCL1 independently of kinase mutations. Connects to BCR::ABL1 (Philadelphia chromosome).
1.Omacetaxine mepesuccinate slips into a pocket on BCR::ABL1 (Philadelphia chromosome).
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
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Adults with chronic or accelerated phase chronic myeloid leukemia with resistance or intolerance to 2 or more TKIs
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
Adults with chronic or accelerated phase chronic myeloid leukemia with resistance or intolerance to 2 or more TKIs
Confirmed: the accelerated approval of 2012 converted to traditional approval 1.3 years after it was granted.
| Region | Year | Indication |
|---|---|---|
| US | 2012 | Chronic or accelerated phase CML resistant or intolerant to two or more TKIs (accelerated; full approval 2014) |
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Query for this drug: (TITLE:"Omacetaxine mepesuccinate" OR ABSTRACT:"Omacetaxine mepesuccinate" OR TITLE:"Synribo" OR ABSTRACT:"Synribo" OR TITLE:"Homoharringtonine" OR ABSTRACT:"Homoharringtonine") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Omacetaxine mepesuccinate, not a curated reading list.
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Shares BCR::ABL1 (Philadelphia chromosome), Chronic myeloid leukaemia (CML).
Shares BCR::ABL1 (Philadelphia chromosome), Chronic myeloid leukaemia (CML).
Shares BCR::ABL1 (Philadelphia chromosome), Chronic myeloid leukaemia (CML).
Shares Study of Lisaftoclax (APG-2575) Single Agent and Combination With Therapy in Patients Relapsed/Refractory AML, BCR::ABL1 (Philadelphia chromosome), Chronic myeloid leukaemia (CML).
Shares BCR::ABL1 (Philadelphia chromosome), Chronic myeloid leukaemia (CML).