Seattle Genetics, Inc. (Nasdaq: SGEN) announced today that ADCETRIS (brentuximab vedotin) has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of mycosis fungoides (MF). MF is the most common type of cutaneous T-cell lymphoma (CTCL). 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 CTCL, including MF. ADCETRIS is not approved for the treatment of CTCL.
“The encouraging data from investigator-sponsored trials of ADCETRIS in CTCL, which will be presented at ASH, provide further support for our activities in this patient population.”
"This orphan drug designation is a part of our ADCETRIS regulatory strategy, designed to complement the Special Protocol Assessment for the ongoing ALCANZA study," said Clay B. Siegall, President and Chief Executive Officer of Seattle Genetics. "The encouraging data from investigator-sponsored trials of ADCETRIS in CTCL, which will be presented at ASH, provide further support for our activities in this patient population."
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.