Belinostat

(Beleodaq®)

Belinostat

Drug updated on 12/11/2024

Dosage FormInjection (intravenous: 500 mg)
Drug ClassHistone deacetylase (HDAC) inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

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Summary
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  • This summary is based on the review of one systematic review(s)/meta-analysis(es). [1]
  • Untreated Peripheral T-cell Lymphoma (PTCL) Patients: High-dose chemotherapy (HDAC) inhibitors demonstrated a pooled complete response (CR) rate of 44% (95% confidence interval (CI), 39-48%) in untreated PTCL patients.
  • Relapsed/Refractory (R/R) PTCL Patients: The pooled CR rate for HDAC inhibitors in R/R PTCL was 14% (95% CI, 11-16%), with combination therapies showing improved efficacy over monotherapy (P = 0.02).
  • Subtype-Specific Response: In R/R Angioimmunoblastic T-cell Lymphoma patients, the pooled overall response rate (ORR) was higher at 44% (95% CI, 35-53%) compared to other PTCL subtypes.
  • Adverse Events in PTCL Treatment with HDAC Inhibitors: Thrombocytopenia was the most commonly reported hematological adverse event, while nausea was the most frequent non-hematological adverse event.
  • Safety Comparisons: The studies did not provide specific safety comparisons between belinostat and other HDAC inhibitors (romidepsin and chidamide), nor did they indicate unique safety concerns specific to subgroups or populations. There is no population types or subgroups information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Beleodaq (belinostat) Prescribing Information.2023Acrotech Biopharma LLC, East Windsor, NJ

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines

Document TitleYearSource
T-Cell Lymphomas, Version 2.2022, NCCN Clinical Practice Guidelines in Oncology.2022Journal of the National Comprehensive Cancer Network