Drugdocs | Beleodaq®

Drug updated on 7/25/2024

Dosage Form	Injection (intravenous: 500 mg (1,000 mg/m2 over 30 minutes))
Drug Class	Histone 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).

Belinostat (Beleodaq) is indicated for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
The information was derived from two systematic reviews/meta-analyses.
In terms of efficacy, belinostat has an overall response rate (ORR) of 10% in monotherapy for relapsed/refractory PTCL, which is lower compared to romidepsin and similar to chidamide.
Combination therapies involving HDAC inhibitors like belinostat show superior efficacy compared to monotherapies, particularly in specific subtypes such as angioimmunoblastic T-cell lymphoma where higher ORRs are observed.
Common adverse events associated with belinostat include thrombocytopenia and nausea; these safety profiles are consistent with other HDAC inhibitors used for treating PTCL and CTCL.
Quality of life impacts were not specifically detailed for individual drugs, including belinostat, within the reviewed studies.

Document Title	Year	Source
Beleodaq (belinostat) prescribing information.	2023	Acrotech Biopharma LLC, East Windsor, NJ

Document Title	Year	Source
Efficacy and safety of histone deacetylase inhibitors in peripheral T-cell lymphoma: A systematic review and meta-analysis on prospective clinical trials.	2023	Frontiers in Oncology
The clinical and humanistic burden of cutaneous T-cell lymphomas and response to conventional and novel therapies: Results of a systematic review.	2020	Expert Review of Hematology

Document Title	Year	Source
T-cell lymphomas, version 2.2022, NCCN clinical practice guidelines in oncology.	2022	Journal of the National Comprehensive Cancer Network