FDA grants Seattle Genetics' Adcetris orphan rating in MF

US biotech firm Seattle Genetics (Nasdaq: SGEN) says its Adcetris (brentuximab vedotin) has been granted orphan drug designation by the US Food and Drug Administration for the treatment of mycosis fungoides (MF), the most common type of cutaneous T-cell lymphoma (CTCL).

Seattle Genetics and its Adcetris collaborator, Millennium, a US unit of Japan’s largest drugmaker Takeda (TYO: 4502), are conducting the ALCANZA trial, a Phase III clinical trial of the drug for patients with CD30-positive relapsed CTCL, including MF, and indication that is not as yet approved by the agency.

“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 Siegall, president and chief executive of Seattle Genetics, adding: “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.”