The US Food and Drug Administration have granted approval to romidepsin for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.
Approval for the drug manufactured by Gloucester Pharmaceuticals was granted on the basis of two single-arm, multi-centre, open-label trials, which examined efficacy in 167 patients with CTCL in the US, Europe, and Australia.
The overall response rates for both trials were similar with rates of 34 and 35% in Study 1 and Study 2, respectively. The median response duration was 15 months in Study 1 and 11 months in Study 2.
The most common adverse reactions in Study 1 were nausea, fatigue, infections, vomiting and anorexia. The most common adverse reactions in Study 2 were nausea, fatigue, anemia, thrombocytopenia, ECG T-wave changes, neutropenia and lymphopenia.