Biology:Belinostat
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| Clinical data | |
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| Trade names | Beleodaq |
| Other names | PXD101 |
| AHFS/Drugs.com | beleodaq |
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| Routes of administration | Intravenous (IV) |
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| Pharmacokinetic data | |
| Bioavailability | 100% (IV) |
| Protein binding | 92.9–95.8%[1] |
| Metabolism | UGT1A1 |
| Excretion | Urine |
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| Formula | C15H14N2O4S |
| Molar mass | 318.35 g·mol−1 |
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Belinostat (trade name Beleodaq, previously known as PXD101) is a histone deacetylase inhibitor drug developed by TopoTarget for the treatment of hematological malignancies and solid tumors.[2]
It was approved in July 2014 by the US FDA to treat peripheral T-cell lymphoma.[3]
In 2007 preliminary results were released from the Phase II clinical trial of intravenous belinostat in combination with carboplatin and paclitaxel for relapsed ovarian cancer.[4] Final results in late 2009 of a phase II trial for T-cell lymphoma were encouraging.[5] Belinostat has been granted orphan drug and fast track designation by the FDA,[6] and was approved in the US for the use against peripheral T-cell lymphoma on 3 July 2014.[3] It is not approved in Europe (As of August 2014).[7]
The approved pharmaceutical formulation is given intravenously.[8]:180 Belinostat is primarily metabolized by UGT1A1; the initial dose should be reduced if the recipient is known to be homozygous for the UGT1A1*28 allele.[8]:179 and 181
References
- ↑ "Beleodaq (belinostat) For Injection, For Intravenous Administration. Full Prescribing Information". Spectrum Pharmaceuticals, Inc. Irvine, CA 92618. http://www.beleodaq.com/downloads/Final_Beleodaq_PI.pdf.
- ↑ "Pharmacodynamic response and inhibition of growth of human tumor xenografts by the novel histone deacetylase inhibitor PXD101". Molecular Cancer Therapeutics 2 (8): 721–8. August 2003. PMID 12939461.
- ↑ 3.0 3.1 "FDA approves Beleodaq to treat rare, aggressive form of non-Hodgkin lymphoma". FDA. 3 July 2014. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm403929.htm.
- ↑ "CuraGen Corporation (CRGN) and TopoTarget A/S Announce Presentation of Belinostat Clinical Trial Results at AACR-NCI-EORTC International Conference". October 2007. http://www.biospace.com/news_story.aspx?NewsEntityId=75000.
- ↑ Final Results of a Phase II Trial of Belinostat (PXD101) in Patients with Recurrent or Refractory Peripheral or Cutaneous T-Cell Lymphoma, December 2009, http://ash.confex.com/ash/2009/webprogram/Paper20945.html
- ↑ Carroll, John (2 February 2010). "Spectrum adds to cancer pipeline with $350M deal.". Fierce Biotech. http://www.fiercebiotech.com/story/spectrum-adds-cancer-pipeline-350m-deal/2010-02-02#ixzz0fBunZz8B.
- ↑ "Neue Wirkstoffe – Belinostat" (in German). Österreichische Apothekerzeitung (16/2014): 27. 4 August 2014.
- ↑ 8.0 8.1 Drug Information Handbook for Oncology (14th ed.). Wolters Kluwer. 2016. ISBN 9781591953517.
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