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Seattle Genetics Inc In Collaboration With Takeda Pharmaceutical Company Limited's The Takeda Oncology Company Receives European Commission Conditional Marketing Authorization For ADCETRIS


Wednesday, 31 Oct 2012 07:00am EDT 

Seattle Genetics Inc announced that its collaborator, Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, announced that the European Commission has granted conditional marketing authorization for ADCETRIS (brentuximab vedotin). ADCETRIS was approved for two indications: the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). As a result, under the collaboration Seattle Genetics will receive two milestone payments from Millennium, one for each indication, totaling $25 million. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. The conditional marketing authorization for ADCETRIS is valid in the 27 member states of the European Union (EU) as well as Norway, Liechtenstein and Iceland. Similar to accelerated approval regulations in the United States, conditional marketing authorizations are granted in the EU to medicinal products that fulfill an unmet medical need with a positive benefit/risk assessment and whose immediate availability would result in a significant public health benefit. 

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30 Jul 2014