Takeda's lymphoma drug Adcetris approved in Japan

Japan’s largest drugmaker Takeda Pharmaceutical (TYO: 4502) has received approval from the country’s Ministry of Health, Labor and Welfare (MHLW) for Adcetris (brentuximab vedotin) for the treatment for patients with CD30 positive or refractory Hodgkin lymphoma (HL) or relapsed or refractory anaplastic large cell lymphoma (ALCL).

The approval was based on a Phase I/II 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, the 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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