Seattle Genetics, Inc. (SGEN) announced that ADCETRIS has been granted orphan drug designation by the U.S. Food and Drug Administration for the treatment of mycosis fungoides, a common type of cutaneous T-cell lymphoma. Seattle Genetics and its ADCETRIS collaborator, Millennium: The Takeda Oncology Company, are conducting the ALCANZA trial, a phase III clinical trial of ADCETRIS for patients with CD30-positive relapsed cutaneous T-cell lymphoma, including MF. ADCETRIS is not approved for the treatment of cutaneous T-cell lymphoma.
The ALCANZA trial is a randomized phase III clinical trial of ADCETRIS for relapsed CD30-positive CTCL patients. The trial is assessing ADCETRIS versus investigator's choice of methotrexate or bexarotene in patients with CD30-positive CTCL, including those with primary cutaneous anaplastic large cell lymphoma or mycosis fungoides. The primary endpoint of the study is overall response rate lasting at least 4 months. Approximately 124 patients will be enrolled in the pivotal trial. The ALCANZA trial is being conducted under a Special Protocol Assessment agreement from the FDA. The study also received European Medicines Agency scientific advice.
FDA orphan drug designation is intended to encourage companies to develop therapies for the treatment of diseases that affect fewer than 200,000 individuals in the United States. This designation provides Seattle Genetics with the opportunity for seven years of marketing exclusivity, grant funding to defray costs of clinical trial expenses, tax credits for clinical research expenses and potential waiver of the FDA's application user fee.
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