Adcetris brentuximab vedotin: Completed Phase III enrollment

Seattle Genetics and Takeda's Millennium Pharmaceuticals Inc. subsidiary completed enrollment of 329 patients in the double-blind, placebo-controlled, international Phase III AETHERA trial evaluating Adcetris brentuximab vedotin every 3 weeks for up to 1 year following autologous stem cell transplant (ASCT). In August 2011, FDA granted accelerated approval for Adcetris to treat Hodgkin's lymphoma and anaplastic large cell lymphoma (ALCL). As part of the approval, Seattle Genetics is required to conduct 2 Phase III confirmatory trials, 1 for each indication. The company had hoped to use the ongoing Phase III AETHERA trial of Adcetris in Hodgkin's lymphoma as a confirmatory trial. However, FDA said AETHERA may be used to fulfill a postmarketing requirement to assess the risk of drug-induced neuropathy (see BioCentury, Aug. 22, 2011). ...