Adcetris brentuximab vedotin: Phase III started

Seattle Genetics and Takeda's Millennium Pharmaceuticals Inc. subsidiary began an open-label, U.S. Phase III trial to compare 1.2 mg/kg IV Adcetris given on days 1 and 15 of a 28-day cycle plus doxorubicin, vinblastine and dacarbazine vs. doxorubicin, vinblastine, dacarbazine plus bleomycin in about 1,040 patients with stage III/IV classical Hodgkin's lymphoma. The trial has a SPA from FDA and received scientific advice from EMA. In August 2011, FDA granted accelerated approval to Adcetris to treat Hodgkin's lymphoma and anaplastic large cell lymphoma (ALCL) and requested Seattle Genetics conduct 2 confirmatory Phase III trials, 1 for each indication. Seattle said this trial may serve as its U.S. confirmatory trial in relapsed Hodgkin's lymphoma and systemic ALCL (see BioCentury, Aug. 22, 2011).

Last week, 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. Adcetris has Orphan Drug status in the U.S. and EU for Hodgkin's lymphoma and ALCL. The product also has Orphan Drug designation for cutaneous T cell lymphoma (CTCL) in the EU. ...