Beleodaq (belinostat)

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Beleodaq (belinostat)

You can order Beleodaq (belinostat) via TheSocialMedwork if the drug has not been approved and/or is not available in the patient's country. TheSocialMedwork - helping patients and doctors access the latest approved medicines and at the lowest price possible worldwide.

Manufacturer Spectrum Pharmaceuticals
Disease Blood Cancer
Indication Peripheral T-cell lymphoma (PTCL)
Mode of Action HDAC inhibitor (chemotherapy)
Approval Status FDA approved (USA)
CAS Number 414864-00-9
HS Code 29350090
Strength 500 mg

Who is belinostat for?

Belinostat is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) [1].

Recommended dose

Complete information about belinostat dosage and administration can be found here [1].
The standard dosage is:
  • 1,000 mg/m2 administered over 30 minutes by intravenous infusion once daily on days 1-5 of a 21-day cycle.
  • Cycles can be repeated until disease progression or unacceptable toxicity.
Treatment discontinuation or interruption with or without dosage reductions by 25 % may be needed to manage adverse reactions [1].
Consult your treating doctor for personalised dosing.

What is belinostat and how does it work?

Belinostat is a histone deacetylase (HDAC) inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), which shows preferential cytotoxicity towards tumour cells compared to normal cells [1].
Peripheral T-cell lymphoma are a group of T-cell lymphomas, blood cell tumours that affect T-cells, that develop away from the thymus. Several physiological and pathological cellular processes in the body are controlled by the balance between protein acetylation and deacetylation. Acetyltransferases (HATs) and deacetylases (HDACs) are enzymes involved in the maintenance of this equilibrium [2]. A dysregulation of the HAT-HDAC balance has been well established as a significant event in lymphoma genesis [3]. HATs is associated with gene transcription while HDAC activity is associated with gene silencing. Altered expression and mutations of genes that encode HDACs have been linked to tumour development since they induce the aberrant transcription of key genes regulating important cellular functions such as cell proliferation, cell-cycle regulation and apoptosis [4].

What is belinostat’s approval status?

Belinostat was approved by
  • FDA (USA) on July 3, 2014 [1]
for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma.
The efficacy of belinostat for relapsed or refractory peripheral T-cell lymphoma was investigated in a multi-centre, single-arm trial of 120 patients with refractory or relapsed PTCL. Belinostat was administered by intravenous infusion at a dose of 1,000 mg/m2 once daily on days 1–5 of a 21 day cycle. The overall response rate (ORR) was 25.8 % (95 % CI (Confidence Interval): 18.3, 34.6). The overall complete and partial response rates were 10.8 % and 15.0 %, respectively. The median response duration (first date of response to disease progression or death) was 8.4 months (95 % CI: 4.5-29.4) [5].
The most common adverse reactions (>25 %) in the safety population (N=129) were nausea, fatigue, pyrexia, anemia, and vomiting. Thrombocytopenia was reported in 16 % of patients with grade 3 or 4 thrombocytopenia in 7 % of patients. Serious adverse reactions were reported in 47 % of patients.  The most common serious adverse reactions (>2 %) were pneumonia, pyrexia, infection, anemia, increased creatinine, thrombocytopenia, and multi-organ failure.  One treatment-related death due to hepatic failure was reported [5].
The European Medicines Agency (EMA) granted orphan designation for belinostat for the treatment of peripheral T-cell lymphoma [6] and malignant thymoma [7].
References
[1] Summary of Product Characteristics [FDA]: Beleodaq (belinostat), Spectrum Pharmaceuticals Inc., Jul. 2014.
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206256lbl.pdf
[2] A. Peserico and C. Simone. Physical and Functional HAT/HDAC Interplay Regulates Protein Acetylation Balance. J Biomed and Biotech. 2011.
http://www.hindawi.com/journals/bmri/2011/371832/
[3] A. Sawas et al. Belinostat in patients with refractory or relapsed peripheral T-cell lymphoma: a perspective review. Ther Adv Hematol. 2015 Aug;6(4):202-208.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4530372/
[4] D. Markozashvili et al. Histone deacetylase inhibitors and epigenetic regulation in lymphoid malignancies. Invest New Drugs. 2015 Dec;33(6):1280-1291.
http://www.moloncol.org/article/S1574-7891(07)00002-6/abstract
[5] FDA. Belinostat, (last update: 30/09/2015), cited on 23/08/2016.
https://wayback.archive-it.org/7993/20170111231655/http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm403960.htm
[6] EMA. Human Medicines: Rare diseases designation: EU/3/12/1055, 16/12/2012, cited on 23/08/2016.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/orphans/2012/11/human_orphan_001130.jsp&mid=WC0b01ac058001d12b
[7] EMA. Human Medicines: Rare diseases designation: EU/3/13/1351, 21/08/2013 (last update: 07/02/2014), cited on 23/08/2016.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/orphans/2013/08/human_orphan_001234.jsp&mid=WC0b01ac058001d12b








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