Romidepsin (Istodax)

Peptide

Romidepsin is a bicyclic depsipeptide histone deacetylase (HDAC) inhibitor derived from Chromobacterium violaceum. FDA-approved November 2009 for relapsed/refractory CTCL and June 2011 for PTCL. Phase 2 CTCL trials: ORR 34-35% with 6% CR. Phase 2 PTCL: ORR 25-38% with durable responses (median DOR 28 months). Acts as prodrug with intracellular disulfide reduction releasing zinc-binding thiol to inhibit HDACs.

Quick Answer

What it is

Romidepsin is a bicyclic depsipeptide histone deacetylase (HDAC) inhibitor derived from Chromobacterium violaceum. FDA-approved November 2009 for relapsed/refractory CTCL and June 2011 for PTCL.

Key findings

Grade A: Overall Response Rate (CTCL) (Cutaneous T-Cell Lymphoma)
Grade A: Pruritus Improvement (CTCL) (Cutaneous T-Cell Lymphoma)
Grade A: Overall Response Rate (PTCL) (Peripheral T-Cell Lymphoma)

Safety

No specific caution or interaction language was detected in the current summary/outcome notes.

⚠️ Research Notice

This peptide information is for educational and research purposes only. Peptides may not be FDA-approved for human use and may only be legally available for research purposes. Consult qualified healthcare professionals before considering any peptide compounds.

ℹ️ Quick Facts: Romidepsin (Istodax)

Quick Facts: Romidepsin (Istodax)

Best Evidence:Grade A
Conditions Studied:2
Research Outcomes:12
Grade A Findings:4
Grade B Findings:2
Key Effect:Cutaneous T-Cell Lymphoma

2 conditions · 12 outcomes

Detailed Outcomes

Overall Response Rate (CTCL)

Two pivotal Phase 2 trials in relapsed/refractory CTCL (n=71, n=96): ORR 34-35% with 6% CR in both studies. Among 68 patients with advanced disease, 38% achieved response including 5 CRs. Led to FDA approval Nov 2009.

moderate↑Improves

Pruritus Improvement (CTCL)

43% (28/65) of patients with moderate-severe pruritus at baseline achieved improvement. Important quality of life benefit in CTCL where pruritus is often debilitating.

moderate↓Improves

Overall Response Rate (PTCL)

Pivotal Phase 2 trial (n=130): ORR 25% with 15% CR/CRu. NCI multicenter study (n=47): ORR 38% with 17% CR. Responses seen across all major PTCL subtypes. Led to FDA approval June 2011.

moderate↑Improves

Duration of Response (PTCL)

Pivotal trial: Median DOR 28 months in responders. NCI trial: Median DOR 8.9 months (range 2-74 months). Durable responses possible in heavily pretreated patients (median 3 prior therapies).

large↑Improves

Response by Prior Therapy

Responses observed regardless of number or type of prior therapies. Patients with up to 11 prior treatments responded. 38% of patients had prior stem cell transplant and still achieved responses.

moderate↑Improves