Belinostat

(Beleodaq®)

Belinostat

Drug updated on 9/4/2024

Dosage FormInjection (intravenous: 500 mg (1,000 mg/m2 over 30 minutes))
Drug ClassHistone deacetylase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

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

Latest News

loading GIF

Summary
This AI-generated content is provided without warranty, with no liability accepted for reliance on it. Learn more.

  • Beleodaq (belinostat) is indicated for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
  • This summary is based on the review of one systematic review(s)/meta-analysis(es). [1]
  • The pooled Complete Response (CR) rate for untreated Peripheral T-cell Lymphoma (PTCL) patients across seven studies (502 patients) was 44% (95% CI, 39-48%).
  • For relapsed/refractory (R/R) PTCL patients, the pooled CR rate across 16 studies was 14% (95% CI, 11-16%). Combination therapy based on HDAC inhibitors showed superior efficacy compared to HDAC inhibitor monotherapy in these patients (P = 0.02).
  • Romidepsin monotherapy had a pooled CR rate of 17% (95% CI, 13-22%) in R/R PTCL patients, compared to belinostat and chidamide monotherapies, both with a pooled CR rate of 10% (95% CI, 5-15%).
  • Thrombocytopenia was the most commonly reported hematological adverse event, while nausea was the most commonly reported non-hematological adverse event in patients treated with HDAC inhibitors.
  • The studies do not provide direct comparative adverse event rates between belinostat and other HDAC inhibitors such as romidepsin or chidamide.
  • 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