The FDA has approved Istodax (romidepsin for injection, from Gloucester Pharmaceuticals), a histone deacetylase inhibitor, for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. This approval was on based on two prospective, multicenter, single-arm studies in patients with CTCL. In both studies, patients could be treated with Istodax until disease progression at the discretion of the investigator and local regulators. 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).

The ORRs in these two trials were similar (34% and 35% in Study 1 and Study 2, respectively) and CR rates were the same (6%). The median response duration was 15 months in Study 1 and 11 months in Study 2. Median time to first response was 2 months in both studies. Median time to CR was 6 months in Study 1 and 4 months in Study 2.

Istodax is expected to be available in January 2010.

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