Romidepsin
Romidepsin is an epigenetic drug for T-cell lymphomas of the skin and lymph nodes; its US lymph-node indication was withdrawn when a confirmatory trial failed.
Approved 2009 for CTCL and 2011 for PTCL (accelerated). Ro-CHOP (2021) failed to improve PFS when added to CHOP, and the PTCL indication was voluntarily withdrawn in 2021; the CTCL indication and use with azacitidine in TFH lymphoma remain. Nausea, fatigue, cytopenias and QT effects.
- Medicare
- Part B (clinician-administered)
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.
- Commercial insurance
- covered on label
Multi-source generic; covered under the medical benefit without prior authorisation in most plans, as part of standard regimens. Prior authorisation is uncommon.
- Assistance programmes
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
- Leukemia & Lymphoma Society financial support
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
- Notes
- EU licence for PTCL withdrawn; no UK licence.
- NHS England
- Not routinely funded
Sources: NICE search: romidepsin. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Approvals
| 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| US | 2011 | Peripheral T-cell lymphoma after ≥1 therapy — Withdrawn 2021 after Ro-CHOP |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery 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.
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