Seattle Genetics, Inc. (NASDAQ:SGEN) today 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: (1) 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 (2) 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 approval of ADCETRIS by the European Commission marks a significant milestone for the product and for the many relapsed or refractory HL and systemic ALCL patients in need of effective new treatment options in Europe,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “In addition to the U.S. and EU approvals of ADCETRIS, we are making regulatory progress for approval in Canada while Millennium and Takeda are pursuing regulatory approvals in other countries. Complementing these regulatory activities is a robust ADCETRIS clinical development program to support our goal of establishing it as the foundation of therapy for CD30-positive malignancies.”
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. Conditional marketing authorization by the European Commission includes obligations to provide additional clinical data at a later stage to confirm the positive benefit-risk assessment. The ADCETRIS Marketing Authorization Application was filed by Takeda Global Research & Development Centre (Europe) to the European Medicines Agency.
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