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January 17, 2014
09:01 EDTSGENSeattle Genetics announces ADCETRIS approval in Japan
Seattle Genetics announced that its collaborator, Takeda Pharmaceutical Company Limited, has received approval of ADCETRIS from the Japanese Ministry of Health, Labour and Welfare for the treatment of patients with CD30-positive relapsed or refractory Hodgkin lymphoma and anaplastic large cell lymphoma. As a result, Seattle Genetics will receive two milestone payments from Takeda totaling $9M upon final pricing agreement in Japan. ADCETRIS is an antibody-drug conjugate directed to CD30, a defining marker of classical HL and known to be expressed in some types of non-Hodgkin lymphoma, including ALCL. The approval of the new drug application was based on two global pivotal phase 2 clinical trials of ADCETRIS, as well as a phase 1/2 clinical trial conducted in Japan, for patients with relapsed or refractory CD30-positive HL and ALCL. In March 2012, the Japanese MHLW granted ADCETRIS orphan drug designation for the treatment of patients with HL and ALCL, which triggered priority review in Japan.
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Healthcare Conference is being held in Scottsdale, Arizona on November 10-13 with webcasted company presentations to begin on November 11 at 10:30 am; not all company presentations may be webcasted. Webcast Link

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