Takeda Announces the New Drug Application Approval of ADCETRIS® (brentuximab vedotin) in Japan for the Treatment of Malignant Lymphoma

New Drug Approval of ADCETRIS® 50mg for intravenous drip infusion for the Treatment for Adult Patients with CD30-Positive Relapsed or Refractory Hodgkin Lymphoma and Relapsed or Refractory Anaplastic Large Cell Lymphoma

Osaka, Japan, January 17, 2014 – Takeda Pharmaceutical Company Limited (“Takeda”) announced today that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the New Drug Application of ADCETRIS® (brentuximab vedotin) (“ADCETRIS”) for the Treatment for Patients with CD30 Positive Relapsed or Refractory Hodgkin Lymphoma (HL) or Relapsed or Refractory Anaplastic Large Cell Lymphoma (ALCL).

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.

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.

"This approval brings us a step closer to providing a new treatment option to patients in Japan with relapsed or refractory HL and relapsed or refractory ALCL," said Michael Vasconcelles, MD, Head of the Oncology Therapeutic Area Unit. "We continually strive to bring more effective treatments to patients in areas with significant unmet medical needs."

Notes to Editors

Approval status of brentuximab vedotin in the US/Canada/EU
In the U.S., ADCETRIS was granted accelerated approval by the U.S. Food and Drug Administration in August 2011 and approval with conditions from Health Canada in February 2013 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.
In the EU, ADCETRIS was granted conditional marketing authorization by the European Commission in October 2012 for the treatment of adult patients with relapsed or refractory CD30+ 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 sALCL.
Seattle Genetics holds commercialization rights in the U.S. and Canada, while Takeda has right to commercialize ADCETRIS in all other countries.

References

Japanese Brand Name ADCETRIS® 50mg for intravenous drip infusion
Generic Name Brentuximab Vedotin (Genetical Recombination)
Dosage and Administration Usually, for adults, the recommended dose of brentuximab vedotin (recombinant) is 1.8mg/kg of body weight administered as an intravenous infusion every 3 weeks. Dose can be reduced based on symptoms by patients.
Indication ADCETRIS is indicated for the treatment of patients with relapsed or refractory CD30-positive :
 Hodgkin lymphoma
 Anaplastic large cell lymphoma

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