FDA to review sBLA to expand Adcetris label

Seattle Genetics Inc. (NASDAQ:SGEN) said FDA accepted for review an sBLA to expand the label of Adcetris brentuximab vedotin to include retreatment and an extended duration of treatment beyond 16 cycles in relapsed Hodgkin's lymphoma and systemic anaplastic large cell lymphoma (ALCL) patients. The PDUFA date is Sept. 14. Adcetris has accelerated approval from FDA and conditional approval from the European Commission for relapsed or refractory systemic ALCL and for relapsed or refractory CD30-positive Hodgkin's lymphoma (see BioCentury Extra, Oct. 31, 2012). ...