Denileukin diftitox is currently approved in the U.S. for treating CD25+ malignancies.

TSD Japan and Eisai signed a license agreement granting TSD rights to co-develop Eisai’s cutaneous T-cell lymphoma (CTCL) therapy, denileukin diftitox, in Japan. Under the terms of the deal Eisai retains exclusive rights to market the product once authorization has been granted.

Denileukin diftitox is indicated for the treatment of CTCL malignancies with CD25-expressing IL-2 receptors. The drug was granted full FDA approval in October 2008, where it is marketed by Eisai under the brand name Ontak®.

The therapy has been available in the U.S. since February 1999, following accelerated approval under the FDA’s Subpart E regulation. This regulation is designed to expedite approval for new drug candidates against life-threatening and severely debilitating illnesses, especially where no satisfactory alternative therapy exists.

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