{"entity":{"id":"omacetaxine","kind":"drug","name":"Omacetaxine mepesuccinate","aka":["Homoharringtonine"],"tldr":"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.","summary":"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.","status":"approved","asOf":"2026-09-10","wikipedia":"https://en.wikipedia.org/wiki/Omacetaxine_mepesuccinate","links":[{"label":"US label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=omacetaxine"},{"label":"NCI drug page","url":"https://www.cancer.gov/about-cancer/treatment/drugs/omacetaxinemepesuccinate"}],"tags":["nci-list"],"related":[],"cancers":["cml"],"sections":[],"technologies":[],"targets":["bcr-abl"],"drugs":[],"companies":["teva"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Synribo","modality":"Protein synthesis inhibitor (cephalotaxine ester)","mechanism":"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.","approvals":[{"region":"US","year":2012,"indication":"Chronic or accelerated phase CML resistant or intolerant to two or more TKIs (accelerated; full approval 2014)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2012-10-26","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"Adults with chronic or accelerated phase chronic myeloid leukemia with resistance or intolerance to 2 or more TKIs"},{"date":"2014-02-10","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2012 converted to traditional approval 1.3 years after it was granted.","indication":"Adults with chronic or accelerated phase chronic myeloid leukemia with resistance or intolerance to 2 or more TKIs"}]},"route":"/drugs/omacetaxine/","neighbours":{"cancer":[{"id":"cml","kind":"cancer","name":"Chronic myeloid leukaemia (CML)","route":"/cancers/cml/"}],"target":[{"id":"bcr-abl","kind":"target","name":"BCR::ABL1 (Philadelphia chromosome)","route":"/targets/bcr-abl/"},{"id":"eef2","kind":"target","name":"Elongation factor 2 (EEF2)","route":"/targets/eef2/"},{"id":"mcl1","kind":"target","name":"MCL1","route":"/targets/mcl1/"}],"company":[{"id":"teva","kind":"company","name":"Teva Pharmaceuticals","route":"/companies/teva/"}],"trial":[{"id":"nct04501120","kind":"trial","name":"Study of Lisaftoclax (APG-2575) Single Agent and Combination With Therapy in Patients Relapsed/Refractory AML","route":"/trials/nct04501120/"}]}}