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Belinostat is an HDAC inhibitor for relapsed peripheral T-cell lymphoma; about a quarter of patients respond, and it can be used in patients with low platelets.
Belinostat is a hydroxamate pan-HDAC inhibitor that blocks class I, II and IV histone deacetylases, increasing acetylation of histones and non-histone proteins with antiproliferative effects in T-cell lymphoma. It is used intravenously in relapsed or refractory peripheral T-cell lymphoma and can be given to patients with low platelet counts, which sets it apart from some alternatives. The BELIEF study (2014) reported a 26% response rate with a median response duration of 10.8 months, supporting accelerated US approval in 2014. The dose is reduced in patients homozygous for UGT1A1*28 because they clear the drug more slowly, and combination with CHOP (Bel-CHOP) has been studied in the front line. Randomised survival evidence is lacking, as for other single-agent PTCL approvals. In short, belinostat helps about a quarter of relapsed PTCL patients and is tolerable when blood counts are poor.
Inhibits class I, II and IV histone deacetylases, increasing acetylation of histone and non-histone proteins with antiproliferative effects in T-cell lymphoma.
1.Belinostat slips into a pocket on its target.
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies.
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
Sources: NICE search: belinostat. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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Treatment of relapsed or refractory peripheral T-Cell Lymphoma (PTCL)
Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 12.2 years later, when the FDA's table was read.
| Region | Year | Indication |
|---|---|---|
| US | 2014 | Relapsed/refractory peripheral T-cell lymphoma |
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Query for this drug: (TITLE:"Belinostat" OR ABSTRACT:"Belinostat" OR TITLE:"Beleodaq" OR ABSTRACT:"Beleodaq") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Belinostat, not a curated reading list.
Shares Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL, To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL, Acrotech Biopharma, Spectrum Pharmaceuticals.
Shares Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL, Histone deacetylases (HDAC), What the NHS in England funds for lymphoma, appraisal by appraisal, Nodal T-follicular helper cell lymphoma, angioimmunoblastic type (angioimmunoblastic T-cell lymphoma).
Shares Histone deacetylases (HDAC), Epigenetic therapy roadmap: loosening silenced genes → mutation-specific enzymes → editing the epigenome, Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET).
Shares Histone deacetylases (HDAC), Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET).
Shares Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET), Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma).
Shares Epigenetic therapy roadmap: loosening silenced genes → mutation-specific enzymes → editing the epigenome, Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET).
Shares Nodal T-follicular helper cell lymphoma, angioimmunoblastic type (angioimmunoblastic T-cell lymphoma), Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET), Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma).
Shares Histone deacetylases (HDAC), Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET).