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FDA Approves Romidepsin Injection for Previously Treated T-Cell Lymphoma
ROCKVILLE, Md -- November 6, 2009 -- The US Food and Drug Administration has approved romidepsin for injection (ISTODAX) for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least 1 prior systemic therapy.
The efficacy and safety of romidepsin were evaluated in 2 single-arm, multicentre, open label trials. Efficacy was assessed in 167 patients with CTCL treated in the United States, Europe, and Australia.
Study 1 included 96 patients with CTCL who had received at least 1 prior systemic therapy. Study 2 included 71 patients with CTCL who received a median of 2 prior systemic therapies.
In both trials, patients could be treated until disease progression. Overall response was evaluated according to a composite endpoint that included assessments of skin involvement, lymph node and visceral involvement, and Sézary cells.
The primary efficacy endpoint for both trials was the overall 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 2 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.
Safety data was available and evaluated in 185 patients with CTCL. 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, anaemia, thrombocytopenia, ECG T-wave changes, neutropenia, and lymphopenia. S
Serious adverse reactions reported in >2% of the patients in study 1 were infection, sepsis, and pyrexia. Serious adverse reactions reported in >2% of the patients in study 2 were infection, supraventricular arrhythmia, neutropenia, fatigue, oedema, central line infection, ventricular arrhythmia, nausea, pyrexia, leukopenia, and thrombocytopenia.
SOURCE: US Food and Drug Administration
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