What is Beleodaq (belinostat) for?
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 cells1. Peripheral T-cell lymphoma are a group of T-cell lymphomas, blood cell tumours that affect T-cells, that develop away from the thymus.
How does Beleodaq (belinostat) work?
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 equilibrium2. A dysregulation of the HAT-HDAC balance has been well established as a significant event in lymphoma genesis3. HATs are 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 apoptosis4.
Where has Beleodaq (belinostat) been approved?
Belinostat was approved for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma by:
Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.
How is Beleodaq (belinostat) taken?
The standard dosage is:
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 reactions1.
Complete information about belinostat dosage and administration can be found in the prescribing information listed in the resources section1.
Note: Please consult with your treating doctor for personalised dosing.
Are there any known side effects of Beleodaq (belinostat)?
Common side effects
The most common side effects (>25%) listed in the prescribing information include1:
Thrombocytopenia was reported in 16% of patients with grade 3 or 4 thrombocytopenia in 7% of patients.
Serious side effects
Serious side effects were reported in 47% of patients. The serious adverse reactions (>2%) listed in the prescribing information include1:
- increased creatinine
- multi-organ failure
- one treatment-related death due to hepatic failure was reported.
The European Medicines Agency (EMA) granted orphan designation for belinostat for the treatment of peripheral T-cell lymphoma6 and malignant thymoma7.