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Oct 26, 2009

Eisai and TSD to Jointly Develop FDA-Approved Cutaneous T-cell Lymphoma Drug in Japan

  • 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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Scientifically Studying Ecstasy

MDMA (commonly known as the empathogen “ecstasy”) is classified as a Schedule 1 drug, which is reserved for compounds with no accepted medical use and a high abuse potential. Two researchers from Stanford, however, call for a rigorous scientific exploration of MDMA's effects to identify precisely how the drug works, the data from which could be used to develop therapeutic compounds.

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