Istodax (romidepsin)

Company
Gloucester Pharmaceuticals

Approval Status
Approved November 2009

Treatment for
cutaneous T-cell lymphoma

Areas
Hematology , Cancer & Oncology

Istodax (romidepsin) is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression. HDACs also deacetylate non-histone proteins, such as transcription factors.

Istodax is specifically indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.

Istodax is supplied as solution for intravenous administration. The recommended dose of romidepsin is 14 mg/m2 administered intravenously over a 4-hour period on days 1, 8 and 15 of a 28-day cycle. Cycles should be repeated every 28 days provided that the patient continues to benefit from and tolerates the therapy.

FDA Approval
The FDA approval of Istodax was was based upon two prospective multicenter, single-arm clinical studies in 167 subjects. The primary efficacy endpoint for both studies was overall objective disease response rate (ORR) based on the investigator assessments and defined as the proportion of patients with confirmed complete response (CR) or partial response (PR).

Study One
This study enrolled 96 patients with confirmed CTCL after failure of at least 1 prior systemic therapy. The subjects were treated with Istodax at a starting dose of 14 mg/m2 infused over 4 hours on days 1, 8, and 15 every 28 days. The overall response rate (ORR) was 34% and the complete response rate was 6%. The median response duration was 15 months and the median time to first response was 2 months. The median time to CR was 6 months.

Study Two
This study enrolled 71 patients with a primary diagnosis of CTCL who received at least 2 prior skin directed therapies or one or more systemic therapies. The subjects were treated with Istodax at a starting dose of 14 mg/m2 infused over 4 hours on days 1, 8, and 15 every 28 days. The ORR was 35% and the CR rate was 6%. The median response duration was 11 months and the median time to first response was 2 months. The median time to CR was 4 months.

Adverse events associated with the use of Istodax may include, but are not limited to, the following:

  • Nausea
  • Asthenia/fatigue
  • Infections
  • Vomiting
  • Anorexia
  • Hypomagnesemia
  • Diarrhea
  • Pyrexia

Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression. HDACs also deacetylate non-histone proteins, such as transcription factors. In vitro, romidepsin causes the accumulation of acetylated histones, and induces cell cycle arrest and apoptosis of some cancer cell lines with IC50 values in the nanomolar range. The mechanism of the antineoplastic effect of romidepsin observed in nonclinical and clinical studies has not been fully characterized.

For additional information regarding Istodax or cutaneous T-cell lymphoma, please visit the Istodax web page.

Istodax (romidepsin) Drug Information

The Istodax (romidepsin) drug information shown above is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.

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