Until recently, patients who suffered a relapse from a type of leukemiaknown as acute promyelocytic leukemia, or APL, had few treatment options. The recent US introduction of Trisenox (arsenic trioxide) injection by Cell Therapeutics has offered these individuals" a potentially highly effective therapy, the firm claims.
"We are impressed at both the high rate of complete remission and the relapse-free survival in this high-risk population of APL patients whose previous treatment failed to eradicate their disease," said Steven Soignet, principal investigator for the pivotal trial that led to US marketing approval of of the drug.
Tisenox received marketing approval from the US Food and Drug Administration in September 2000 and, following its US launch, Cell Therapeutics submitted and obtained an orphan drug designation from the European Commission. Subsequently, the firm submitted a Marketing Authorization Application to the European Medicines Evaluation Agency on the product for the treatment of relapsed APL. The MAA is pending approval.
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