Omacetaxine mepesuccinate
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.
Overview
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.
- AmivantamabApproved
- CamizestrantApproved
- Comprehensive genomic profilingStandard of care
- Liquid biopsy (ctDNA)Standard of care
- LorlatinibApproved
- MRD / molecular residual disease testingEstablished
- ADC payload neutralisersPhase 1
- BGB-16673Phase 3
- Bispecific ADCPhase 3
- BRUIN CLL-321Positive
- CaDAnCe-304Recruiting
- CIRCULATE-Japan (GALAXY / VEGA / ALTAIR)Active
- A clone report from blood at every treatment cycle
- A fast route to the matched drug when it is licensed for another cancer
- A multi-cancer platform trial of adaptive (dose-holiday) therapy
- A national rapid research autopsy network for end-stage cancer
- A standard evolvability score for every tumour
- A standing platform trial that assigns treatment by how the tumour escaped
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance atlas: how tumours escape and what closes the route · Lines of therapy.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2012 | Chronic or accelerated phase CML resistant or intolerant to two or more TKIs (accelerated; full approval 2014) |
Trials
topRecruiting now (live from ClinicalTrials.gov)
Country and place are remembered in this browser only. A postcode is sent to OpenStreetMap's Nominatim service to find coordinates when you press the button; nothing else leaves your device.
Latest papers
topQuery 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.
Pages like this
not linked directly; found by shared links- ProductBusulfan
Shares Chronic myeloid leukaemia (CML) and the tag nci-list.
- ProductFilgrastim (G-CSF)
Shares Teva Pharmaceuticals and the tag nci-list.
- ProductCytarabine
Shares Chronic myeloid leukaemia (CML) and the tag nci-list.
- ProductBosutinib
Shares BCR::ABL1 (Philadelphia chromosome), Chronic myeloid leukaemia (CML).
- InstitutionFox Chase Cancer Center
Shares BCR::ABL1 (Philadelphia chromosome), Chronic myeloid leukaemia (CML).
- PersonBud Romine
Shares BCR::ABL1 (Philadelphia chromosome), Chronic myeloid leukaemia (CML).
- Key paperFirst imatinib trial: a pill that switched off the enzyme driving chronic myeloid leukaemia
Shares BCR::ABL1 (Philadelphia chromosome), Chronic myeloid leukaemia (CML).
- PersonJanet Rowley
Shares BCR::ABL1 (Philadelphia chromosome), Chronic myeloid leukaemia (CML).