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Ref Type
PMID
Authors
Title Istodax (romidepsin) FDA Drug Label
Journal
Vol
Issue
Date
URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022393
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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Romidepsin Romidepsin 3 10
Drug Name Trade Name Synonyms Drug Classes Drug Description
Romidepsin Istodax FK228|FR901228|NSC 630176|depsipeptide HDAC Inhibitor 38 Istodax (romidepsin) inhibits Class I HDACs, resulting in cell cycle arrest, apoptosis, and decreased tumor cell growth (PMID: 12208741, PMID: 12234611, PMID: 21258344). Istodax (romidepsin) is FDA approved for patients with cutaneous T-cell lymphoma (FDA.gov).
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown cutaneous T cell lymphoma not applicable Romidepsin FDA approved Actionable In clinical trials that supported FDA approval, treatment with Istodax (romidepsin) produced a 35% (34/96) response rate in patients with cutaneous T cell lymphoma (PMID: 20697094). detail... 20697094