Adcetris brentuximab vedotin: Phase III started

Seattle Genetics began an open-label, international Phase III trial to compare 1.8 mg/kg IV Adcetris every 21 days for up to 48 weeks vs. investigator's choice of methotrexate or bexarotene in about 124 CD30-positive CTLC patients, including those with primary cutaneous anaplastic large cell lymphoma or mycosis fungoides. The trial has a SPA from FDA and received scientific advice from EMA. Seattle said the trial is screening for CD30-positive patients using a companion diagnostic test being developed by Seattle Genetics, Takeda's Millennium Pharmaceuticals Inc. unit and the Ventana Medical Systems Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY, Basel, Switzerland) (see BioCentury, April 16).

Adcetris has accelerated approval in the U.S. to treat Hodgkin's lymphoma and anaplastic large cell lymphoma (ALCL) (see BioCentury, Aug. 22, 2011). The compound has Orphan Drug designation in the U.S. and EU for both indications, and Fast Track designation in the U.S. to treat Hodgkin's lymphoma. ...