The United States Food and Drug Administration (FDA) has granted Eisai Pharmaceuticals full approval for their agent Ontak (denileukin diftitox). Ontak is now approved for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose cancer cells express the CD25 component of the IL-2 receptor.
Ontak consists of the sequence of interleukin-2 (IL-2) fused with a genetically engineered protein from a portion of the diptheria toxin. Ontak binds to the IL-2 portion of the malignant cell and delivers the diptheria toxin, resulting in cellular death.
The approval was prompted by a phase III trial directly comparing Ontak to placebo in patients with cutaneous T-cell lymphoma whose cancer cells expressed the CD25 component of the IL-2 receptor and who were resistant to other therapies.
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