Loading
Romidepsin is an epigenetic drug for T-cell lymphomas of the skin and lymph nodes; its US lymph-node indication was withdrawn when a confirmatory trial failed.
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failed to improve progression-free survival when romidepsin was added to CHOP, and the PTCL indication was voluntarily withdrawn in 2021.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.
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.
1.Romidepsin slips into a pocket on its target.
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
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. Generic romidepsin is available.
Multi-source generic; covered under the medical benefit without prior authorisation in most plans, as part of standard regimens. Prior authorisation is uncommon.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
Sources: NICE search: romidepsin. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Compare all products across the US, EU, UK, Japan, China and Australia →
Peripheral T-cell lymphoma in patients who have received at least one prior therapy
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
Formulation: Treatment of peripheral T-cell lymphoma in adults who have received at least one prior therapy
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
Peripheral T-cell lymphoma in patients who have received at least one prior therapy
Withdrawn: the indication came off the label 10.1 years after its accelerated approval.
Formulation: Treatment of peripheral T-cell lymphoma in adults who have received at least one prior therapy
Withdrawn: the indication came off the label 1.7 years after its accelerated approval.
| Region | Year | Indication |
|---|---|---|
| US | 2009 | Cutaneous T-cell lymphoma after ≥1 systemic therapy |
| US | 2011 | Peripheral T-cell lymphoma after ≥1 therapy · Withdrawn 2021 after Ro-CHOP |
Country and place are remembered in this browser only. A postcode is sent to OpenStreetMap's Nominatim service to find coordinates when you press the button; nothing else leaves your device.
Query for this drug: (TITLE:"Romidepsin" OR ABSTRACT:"Romidepsin" OR TITLE:"Istodax" OR ABSTRACT:"Istodax") 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 Romidepsin, not a curated reading list.
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 Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL, What the NHS in England funds for lymphoma, appraisal by appraisal, Nodal T-follicular helper cell lymphoma, angioimmunoblastic type (angioimmunoblastic T-cell lymphoma), Sezary syndrome.
Shares Resminostat, Sezary syndrome, Cutaneous T-cell lymphoma (mycosis fungoides and Sezary syndrome), Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma).
Shares Vorinostat, Mycosis fungoides, Sezary syndrome, Cutaneous T-cell lymphoma (mycosis fungoides and Sezary syndrome).
Shares Resminostat, Histone deacetylases (HDAC), Cutaneous T-cell lymphoma (mycosis fungoides and Sezary syndrome), Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET).
Shares Vorinostat, Mycosis fungoides, Sezary syndrome, Cutaneous T-cell lymphoma (mycosis fungoides and Sezary syndrome).
Shares Vorinostat, Mycosis fungoides, Sezary syndrome, Cutaneous T-cell lymphoma (mycosis fungoides and Sezary syndrome).
Shares TET2, RHOA G17V, Nodal T-follicular helper cell lymphoma, angioimmunoblastic type (angioimmunoblastic T-cell lymphoma), Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma).