Takeda Pharmaceutical Company Limited (Takeda) and Millennium: The Takeda Oncology Company (Millennium), a wholly-owned subsidiary of Takeda, have submitted a new drug application in Japan to the Ministry of Health, Labour 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).

The submission was made based on a pivotal phase 1/2 clinical trial evaluating the safety, tolerability and efficacy of brentuximab vedotin conducted in Japan by Takeda Bio Development Center Limited, 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 2 clinical trials were also used to support the new drug application in Japan. In March 2012, MHLW granted brentuximab vedotin orphan product designations for the treatment of patients with HL and ALCL in Japan.

“This filing brings us a step closer to providing a new treatment option to patients in Japan with relapsed or refractory Hodgkin lymphoma and relapsed or refractory anaplastic large cell lymphoma - two areas of high unmet medical need,” said Karen Ferrante,  chief medical officer of Millennium, “We look forward to working with the regulatory authorities to deliver this innovative CD30 targeted treatment option to patients in Japan as quickly as possible.”

Brentuximab vedotin (Adcetris) is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics' proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

Adcetris was granted accelerated approval by the US Food and Drug Administration in August 2011 for two indications: (1) the treatment of patients with HL after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and (2) the treatment of patients with sALCL after failure of at least one prior multi-agent chemotherapy regimen.

Adcetris was granted conditional marketing authorization by the European Commission in October 2012 for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL): (1) following autologous stem cell transplant (ASCT) or (2) following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option. Adcetris is indicated for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL).

Seattle Genetics and Millennium are jointly developing Brentuximab vedotin. Under the terms of the collaboration agreement, Seattle Genetics has US and Canadian commercialization rights and the Takeda Group has rights to commercialize Brentuximab vedotin in the rest of the world. Seattle Genetics and the Takeda Group are funding joint development costs for Brentuximab vedotin on a 50:50 basis, except in Japan where the Takeda Group will be solely responsible for development costs.

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine.

Millennium: The Takeda Oncology Company, a leading biopharmaceutical company based in Cambridge, Mass., markets Velcade, a first-in-class proteasome inhibitor, and has a robust clinical development pipeline of product candidates. Millennium Pharmaceuticals, Inc. was acquired by Takeda Pharmaceutical Company Ltd. in May, 2008.