{"entity":{"id":"romidepsin","kind":"drug","name":"Romidepsin","aka":[],"tldr":"Romidepsin is an epigenetic drug for T-cell lymphomas of the skin and lymph nodes; its US lymph-node indication was withdrawn when a confirmatory trial failed.","summary":"Romidepsin is a cyclic peptide inhibitor of class I histone deacetylases 1 and 2; it induces histone hyperacetylation, cell-cycle arrest and apoptosis, and is particularly active in T-cell lymphomas of follicular helper type that carry TET2 or DNMT3A mutations. It was approved in the US in 2009 for cutaneous T-cell lymphoma after at least one systemic therapy and in 2011, under accelerated approval, for peripheral T-cell lymphoma. The Ro-CHOP trial (2021) failed to improve progression-free survival when romidepsin was added to CHOP, and the PTCL indication was voluntarily withdrawn in 2021. The CTCL indication remains, and use with azacitidine in TFH lymphoma is an active area. Nausea, fatigue, cytopenias and QT prolongation are the main toxicities. Romidepsin is an epigenetic drug that works for skin T-cell lymphoma but could not prove itself in a randomised trial in nodal disease.","status":"approved","asOf":"2026-09-08","wikipedia":"https://en.wikipedia.org/wiki/Romidepsin","links":[{"label":"Label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=romidepsin"}],"tags":["gap-fill"],"related":[],"cancers":["peripheral-t-cell-lymphoma","cutaneous-t-cell-lymphoma"],"sections":[],"technologies":["epigenetic-drugs"],"targets":[],"drugs":[],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":["nct04747236","nct00106431","nct00112463"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Istodax","modality":"Class I HDAC inhibitor (cyclic peptide)","mechanism":"Inhibits histone deacetylases 1/2, inducing histone hyperacetylation, cell-cycle arrest and apoptosis; activity in T-cell lymphomas including TFH type with TET2/DNMT3A mutations.","approvals":[{"region":"US","year":2009,"indication":"Cutaneous T-cell lymphoma after ≥1 systemic therapy"},{"region":"US","year":2011,"indication":"Peripheral T-cell lymphoma after ≥1 therapy","note":"Withdrawn 2021 after Ro-CHOP"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2011-06-16","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"Peripheral T-cell lymphoma in patients who have received at least one prior therapy"},{"date":"2020-03-13","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"Formulation: Treatment of peripheral T-cell lymphoma in adults who have received at least one prior therapy"},{"date":"2021-07-30","type":"withdrawal","region":"US","note":"Withdrawn: the indication came off the label 10.1 years after its accelerated approval.","indication":"Peripheral T-cell lymphoma in patients who have received at least one prior therapy"},{"date":"2021-12-08","type":"withdrawal","region":"US","note":"Withdrawn: the indication came off the label 1.7 years after its accelerated approval.","indication":"Formulation: Treatment of peripheral T-cell lymphoma in adults who have received at least one prior therapy"}]},"route":"/drugs/romidepsin/","neighbours":{"cancer":[{"id":"cutaneous-t-cell-lymphoma","kind":"cancer","name":"Cutaneous T-cell lymphoma (mycosis fungoides and Sezary syndrome)","route":"/cancers/cutaneous-t-cell-lymphoma/"},{"id":"mycosis-fungoides","kind":"cancer","name":"Mycosis fungoides","route":"/cancers/mycosis-fungoides/"},{"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/"},{"id":"sezary-syndrome","kind":"cancer","name":"Sezary syndrome","route":"/cancers/sezary-syndrome/"}],"technology":[{"id":"epigenetic-drugs","kind":"technology","name":"Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET)","route":"/technologies/epigenetic-drugs/"}],"company":[{"id":"bms","kind":"company","name":"Bristol Myers Squibb","route":"/companies/bms/"}],"trial":[{"id":"nct00106431","kind":"trial","name":"A Single Agent Phase II Study of Romidepsin (Depsipeptide, FK228) in the Treatment of Cutaneous T-cell Lymphoma (CTCL)","route":"/trials/nct00106431/"},{"id":"nct00112463","kind":"trial","name":"Depsipeptide (Romidepsin) in Treating Patients With Metastatic or Unresectable Soft Tissue Sarcoma","route":"/trials/nct00112463/"},{"id":"nct04747236","kind":"trial","name":"Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL","route":"/trials/nct04747236/"}],"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/"}],"biomarker":[{"id":"rhoa-g17v","kind":"biomarker","name":"RHOA G17V","route":"/biomarkers/rhoa-g17v/"}],"drug":[{"id":"resminostat","kind":"drug","name":"Resminostat","route":"/drugs/resminostat/"},{"id":"vorinostat","kind":"drug","name":"Vorinostat","route":"/drugs/vorinostat/"}],"target":[{"id":"hdac","kind":"target","name":"Histone deacetylases (HDAC)","route":"/targets/hdac/"},{"id":"tet2","kind":"target","name":"TET2","route":"/targets/tet2/"}],"roadmap":[{"id":"epigenetics-roadmap","kind":"roadmap","name":"Epigenetic therapy roadmap: loosening silenced genes → mutation-specific enzymes → editing the epigenome","route":"/roadmaps/epigenetics-roadmap/"}]}}