Drug updated on 9/4/2024
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).
Latest News
Summary
- 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 Title | Year | Source |
---|---|---|
Beleodaq (belinostat) prescribing information. | 2023 | Acrotech Biopharma LLC, East Windsor, NJ |
Systematic Reviews / Meta-Analyses
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 |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
T-cell lymphomas, version 2.2022, NCCN clinical practice guidelines in oncology. | 2022 | Journal of the National Comprehensive Cancer Network |