{"entity":{"id":"belinostat","kind":"drug","name":"Belinostat","aka":[],"tldr":"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.","summary":"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.","status":"approved","asOf":"2026-09-08","wikipedia":"https://en.wikipedia.org/wiki/Belinostat","links":[{"label":"Label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=belinostat"}],"tags":["gap-fill"],"related":[],"cancers":["peripheral-t-cell-lymphoma"],"sections":[],"technologies":["epigenetic-drugs"],"targets":[],"drugs":[],"companies":["acrotech-biopharma","spectrum-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":["nct06072131"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Beleodaq","modality":"Pan-HDAC inhibitor (hydroxamate)","mechanism":"Inhibits class I, II and IV histone deacetylases, increasing acetylation of histone and non-histone proteins with antiproliferative effects in T-cell lymphoma.","approvals":[{"region":"US","year":2014,"indication":"Relapsed/refractory peripheral T-cell lymphoma"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2014-07-03","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 12.2 years later, when the FDA's table was read.","indication":"Treatment of relapsed or refractory peripheral T-Cell Lymphoma (PTCL)"}]},"route":"/drugs/belinostat/","neighbours":{"cancer":[{"id":"angioimmunoblastic-t-cell-lymphoma","kind":"cancer","name":"Nodal T-follicular helper cell lymphoma, angioimmunoblastic type (angioimmunoblastic T-cell lymphoma)","route":"/cancers/angioimmunoblastic-t-cell-lymphoma/"},{"id":"peripheral-t-cell-lymphoma","kind":"cancer","name":"Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma)","route":"/cancers/peripheral-t-cell-lymphoma/"}],"technology":[{"id":"epigenetic-drugs","kind":"technology","name":"Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET)","route":"/technologies/epigenetic-drugs/"}],"company":[{"id":"acrotech-biopharma","kind":"company","name":"Acrotech Biopharma","route":"/companies/acrotech-biopharma/"},{"id":"spectrum-pharmaceuticals","kind":"company","name":"Spectrum Pharmaceuticals","route":"/companies/spectrum-pharmaceuticals/"}],"trial":[{"id":"nct04747236","kind":"trial","name":"Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL","route":"/trials/nct04747236/"},{"id":"nct06072131","kind":"trial","name":"To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL","route":"/trials/nct06072131/"}],"term":[{"id":"lymphoma-tx-uk-access","kind":"term","name":"What the NHS in England funds for lymphoma, appraisal by appraisal","route":"/terms/lymphoma-tx-uk-access/"}],"target":[{"id":"hdac","kind":"target","name":"Histone deacetylases (HDAC)","route":"/targets/hdac/"}],"roadmap":[{"id":"epigenetics-roadmap","kind":"roadmap","name":"Epigenetic therapy roadmap: loosening silenced genes → mutation-specific enzymes → editing the epigenome","route":"/roadmaps/epigenetics-roadmap/"}]}}