Romidepsin
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
| ID | DRUG-ROMIDEPSIN |
|---|---|
| Type | Drug |
| Aliases | IstodaxРомідепсин |
| Status | reviewed 2026-04-25 | pending_clinical_signoff |
| Diseases | DIS-AITL DIS-PTCL-NOS |
| Sources | SRC-NCCN-BCELL-2025 |
Drug Facts
| Class | HDAC inhibitor (cyclic peptide; HDAC1/2 selective) |
|---|---|
| Mechanism | Bicyclic depsipeptide HDAC inhibitor with greater selectivity for class I HDAC (HDAC1, HDAC2) — increases histone acetylation, derepresses tumor-suppressor genes, induces apoptosis in T-cell malignancies. Particularly active in PTCL with epigenetic dysregulation. Note: FDA initially approved for PTCL but voluntarily withdrew PTCL indication in 2021 (post-marketing Ro-CHOEP trial showed no PFS benefit over CHOP); CTCL indication retained. Still used internationally per NCCN guidance for r/r PTCL after individual benefit-risk discussion. |
| Typical dosing | 14 mg/m² IV over 4 hours on days 1, 8, 15 of each 28-day cycle, until progression or unacceptable toxicity |
| Ukraine registered | False |
| NSZU reimbursed | False |
| Ukraine last verified | 2026-04-27 |
Notes
NCI 1312 / Coiffier 2012: r/r PTCL — ORR 25-38% (CR 15%); mDOR 17 mo. FDA initially approved for r/r PTCL (2011) AND CTCL (2009); PTCL indication voluntarily withdrawn 2021 after Ro-CHOEP confirmatory trial (PFS not superior to CHOP). CTCL indication retained. NCCN still lists romidepsin for r/r PTCL after individual benefit-risk discussion. Particularly active in AITL (TFH-cell origin, epigenetic dysregulation TET2/IDH2/DNMT3A). Major UA access barrier: not registered.
Used By
Regimens
REG-ROMIDEPSIN-PTCL- Romidepsin IV days 1, 8, 15 q28d — r/r PTCL incl AITL