Difference between revisions of "Omacetaxine (Synribo)"
(FDA approval) |
m |
||
| Line 1: | Line 1: | ||
| − | '''FDA approved 10/26/2012'''. Also known as HHT, homoharringtonine, or | + | '''FDA approved 10/26/2012'''. Also known as HHT, homoharringtonine, Omapro, or omacetaxine mepesuccinate. |
==General information== | ==General information== | ||
Revision as of 23:06, 26 October 2012
FDA approved 10/26/2012. Also known as HHT, homoharringtonine, Omapro, or omacetaxine mepesuccinate.
General information
Class/mechanism: Cephalotaxine ester & natural alkaloid that inhibits protein synthesis/translation/elongation; prepared via a semi-synthetic process from cephalotaxine, an extract of Cephalotaxus species leaves. Mechanism is not fully understood, but omacetaxine mepesuccinate inhibits protein synthesis and promotes apoptosis in a manner that does not involve direct binding of Bcr-Abl. Omacetaxine mepesuccinate has been observed to bind to the A-site cleft in the large ribosomal subunit of a type of archaeabacteria. It reduces levels of Bcr-Abl and human induced myeloid leukemia cell differentiation protein Mcl-1, an anti-apoptotic Bcl-2 family member. Omacetaxine mepesuccinate has been seen to have activity in mouse models with wild-type Bcr-Abl, as well as imatinib-resistant chronic myeloid leukemia (CML) models with the T315I mutation.[1][2][3]
Route: IV, SC
Extravasation: no information
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it is used
Clinical trials
- Subcutaneous omacetaxine mepesuccinate in patients with chronic phase (CP) or accelerated phase (AP) chronic myeloid leukemia (CML) resistant/intolerant to two or three approved tyrosine-kinase inhibitors (TKIs) (2012 ASCO Annual Meeting Abstract 6513)
- Omacetaxine and Low Dose Cytarabine in Older Patients With Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
- Pharmacokinetic (PK) Study of Homoharringtonine (Omacetaxine Mepesuccinate) Administered Subcutaneously to Patients With Advanced Solid and Hematologic Tumors
- Open Label Study of Subcutaneous Homoharringtonine (Omacetaxine Mepesuccinate) in Patients With Advanced CML
- Homoharringtonine (Omacetaxine Mepesuccinate) in Treating Patients With Chronic Myeloid Leukemia (CML) With the T315I BCR-ABL Gene Mutation[4]
- Homoharringtonine With Oral Gleevec in Chronic, Accelerated and Blast Phase Chronic Myeloid Leukemia (CML)
- Chemotherapy and Biological Therapy in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia
- Homoharringtonine in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia
- Homoharringtonine and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia
Patient drug information
- Brief patient counseling information can be found on page 10 of the Omacetaxine mepesuccinate (Synribo) package insert[1]
History of changes in FDA indication
- 10/26/2012: FDA approved for "treatment of adult patients with chronic or accelerated phase chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKI)."[1]
References
- ↑ 1.0 1.1 1.2 1.3 Omacetaxine mepesuccinate (Synribo) package insert
- ↑ Omacetaxine mepesuccinate (Synribo) package insert (locally hosted backup)
- ↑ Quintás-Cardama A, Kantarjian H, Cortes J. Homoharringtonine, omacetaxine mepesuccinate, and chronic myeloid leukemia circa 2009. Cancer. 2009 Dec 1;115(23):5382-93. link to original article PubMed
- ↑ Cortes J, Lipton JH, Rea D, Digumarti R, Chuah C, Nanda N, Benichou AC, Craig AR, Michallet M, Nicolini FE, Kantarjian H; on behalf of the Omacetaxine 202 Study Group. Phase 2 study of subcutaneous omacetaxine mepesuccinate after TKI failure in patients with chronic-phase CML with T315I mutation. Blood. 2012 Sep 27;120(13):2573-2580. Epub 2012 Aug 15. link to original article contains verified protocol PubMed