Adcetris brentuximab vedotin: SPA received

Seattle Genetics disclosed in its 3Q12 earnings that it received an SPA from FDA for a planned Phase III trial to evaluate Adcetris for first-line treatment of mature T cell lymphomas, including systemic anaplastic large cell lymphoma (ALCL). The biotech expects to start the trial by late 2012 or early 2013. In August 2011, FDA granted accelerated approval to Adcetris to treat Hodgkin's lymphoma and ALCL and requested Seattle Genetics conduct 2 confirmatory Phase III trials, 1 for each indication. In October, the European Commission granted conditional approval of Adcetris for relapsed or refractory systemic ALCL and for relapsed or refractory CD30-positive Hodgkin's lymphoma following autologous stem cell transplant (ASCT) or following >=2 prior therapies when ASCT or multi-agent chemotherapy is not a treatment option.

Earlier this month, Seattle Genetics and Takeda's Millennium Pharmaceuticals Inc. subsidiary began a U.S. Phase III trial of Adcetris for first-line treatment of Hodgkin's lymphoma (see BioCentury, Nov. 5). The trial has a SPA from FDA and received scientific advice from EMA. ...