On November 5, 2009, the U.S. Food and Drug Administration granted approval to romidepsin for injection (ISTODAX, Gloucester Pharmaceuticals Inc.) for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.
The efficacy and safety of romidepsin were evaluated in two single-arm, multicenter, open label trials. Efficacy was assessed in 167 patients with CTCL treated in the United States, Europe, and Australia.
The recommended dose and schedule of romidepsin is 14 mg/m2 intravenously over 4 hours on days 1, 8 and 15 of a 28-day cycle.
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