On January 17, 2014 Takeda reported that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the New Drug Application of ADCETRIS (brentuximab vedotin) for the Treatment for Patients with CD30 Positive Relapsed or Refractory Hodgkin Lymphoma (HL) or Relapsed or Refractory Anaplastic Large Cell Lymphoma (ALCL) (Press release Takeda, JAN 17, 2014, View Source [SID:1234500441]).
The application approval was based on a phase 1/2 clinical trial in Japanese patients with relapsed or refractory CD30-positive HL and patients with relapsed or refractory CD30-positive systemic ALCL, and data from two global pivotal phase 2 clinical trials. In March 2012, MHLW granted ADCETRIS orphan drug designation for the treatment of patients with HL and ALCL, and therefore was targeted for priority review in Japan.

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