Seragen Files BLA For T-Cell Lymphoma Drug

Seragen has submitted a Biologics License Application to the US Food andDrug Administration requesting approval to market DAB389IL-2 (denileukin diftitox) for the treatment of recurrent or persistent cutaneous T cell lymphoma.

A Phase III trial of the drug, which is being developed in collaboration with Eli Lilly for this indication, included 71 patients with advanced CTCL who had failed an average of five previous therapies.

Results showed that 30% of DAB389IL-2-treated patients had a partial response, with 10% of patients experiencing a complete response. Side effects included flu-like symptoms and the development of a vascular leak disorder. 37% of patients withdrew from the trial as a result of adverse events including arrhythmia, unstable angina, confusion and amnesia.