Takeda files for brentuximab vedotin approval in Japan; sanctioned by JPMA

Japan’s largest drugmaker, Takeda Pharmaceutical (TYO: 4502) and its oncology subsidiary Millennium have submitted a new drug application to Japan’s Ministry of Health, Labor and Welfare (MHLW) for brentuximab vedotin for the treatment of adult patients with relapsed or refractory CD30 positive Hodgkin lymphoma (HL) and relapsed or refractory CD30 positive anaplastic large cell lymphoma (ALCL).

Seattle Genetics (Nasdaq: SGEN) and Millennium are jointly developing brentuximab vedotin, which the former already markets in the USA and has recently gained approval in Canada (the two territories for which it has commercialization rights) under the trade name Adcetris.

The Japanese submission was made based on a pivotal Phase I/II clinical trial evaluating the safety, tolerability and efficacy of brentuximab vedotin conducted in Japan by Takeda Bio Development Center, a wholly-owned subsidiary of Takeda, in patients with relapsed or refractory CD30 positive HL and relapsed or refractory CD30 positive systemic ALCL. Results from this clinical trial will be presented at a future medical meeting. Data from two global pivotal Phase II clinical trials were also used to support the new drug application in Japan. In March 2012, the MHLW granted brentuximab vedotin orphan product designations for the treatment of patients with HL and ALCL in Japan.