Drugdocs | Beleodaq®

Drug updated on 4/16/2024

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) and has shown promising results, particularly as part of combination therapies.
Two studies were reviewed to gather information about Beleodaq, providing insights into its efficacy and safety profile compared to other drugs.
In terms of efficacy, belinostat showed a complete response rate of 14% in relapsed or refractory PTCL cases, slightly lower than romidepsin, which had a response rate of 17%, but higher than chidamide at 10%.
The drug demonstrated increased effectiveness within certain subgroups; specifically, it achieved an overall response rate (ORR) as high as 44% among patients with angioimmunoblastic T-cell lymphoma, a subtype of PTCL.
Common adverse events associated with belinostat include thrombocytopenia and nausea. However, these side effects are considered manageable and do not significantly distinguish Beleodaq unfavorably from alternative treatments in terms of safety profile.
When treating cutaneous T-cell lymphomas (CTCL), alternatives such as brentuximab vedotin and bexarotene may be more effective, given their ORRs exceeding 50%. As such, while Beleodaq remains valuable for treating PTCL, especially in relapsed or refractory settings, there might be safer and more effective options available depending on individual patient conditions.

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