title: Romidepsin: a novel histone deacetylase inhibitor for cancer.
abstract: BACKGROUND
  Romidepsin is a novel histone deacetylase (HDAC) inhibitor, with a recent approval for treatment of cutaneous T-cell lymphoma (CTCL). HDAC inhibitors represent a novel approach to anti-tumor therapy. In contrast to traditional cytotoxic chemotherapy, HDAC inhibitors target underlying epigenetic changes leading to malignant transformation. Further study of romidepsin and similar agents in solid and hematologic malignancies is ongoing.
  
  
  METHODS
  This review discusses the development of romidepsin, its mechanism of action, pivotal clinical trials, drug toxicity and its recent approval for CTCL treatment. Key clinical trials covered include Phase I/II testing of romidepsin in solid and hematologic malignancies. In addition, the Phase II trial in CTCL leading to FDA approval of romidepsin is reviewed in detail. Literature search was performed using PubMed; keywords and concepts used included romidepsin, T-cell lymphoma and HDAC inhibitors.
  
  
  CONCLUSIONS
  Romidepsin is a potent HDAC inhibitor with demonstrable activity in T-cell lymphoma. In contrast to vorinostat, romidepsin is approved as second-line therapy. Current approval only includes CTCL; promising results have been demonstrated in Phase II testing of peripheral T-cell lymphoma subtypes. Future directions include expanded indications in T-cell lymphomas as well as novel combinations with other HDAC inhibitors and other therapeutic agents.
authors.affiliation: The Ohio State University, Comprehensive Cancer Center, Department of Internal Medicine, Columbus, USA.
authors.forename: Erin M
authors.initials: EM
authors.lastname: Bertino
authors.forename: Gregory A
authors.initials: GA
authors.lastname: Otterson
mesh_terms: D000818:Animals; D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D047630:Depsipeptides / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use*; D056572:Histone Deacetylase Inhibitors / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use*; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*
chemical_list: D047630:Depsipeptides; D056572:Histone Deacetylase Inhibitors; C087123:romidepsin