Osaka, Japan, April 17, 2014 – Takeda Pharmaceutical Company Limited (“Takeda”) announced today that "ADCETRIS® 50mg for intravenous drip infusion" (brentuximab vedotin) (“ADCETRIS”) is now available for the treatment for patients with CD30 Positive Relapsed or Refractory Hodgkin Lymphoma (HL) or Relapsed or Refractory Anaplastic Large Cell Lymphoma (ALCL) in Japan. ADCETRIS received orphan drug designation from the Ministry of Health, Labour and Welfare (MHLW) in March 2012, and Japanese manufacturing and marketing authorization on January 17th 2014. Additionally, ADCETRIS was placed on the country's National Health Insurance drug price list today, April 17th 2014.
ADCETRIS is an antibody-drug conjugate (ADC) comprised of 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 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 who still have significant unmet medical needs," said Masato Iwasaki, Director and Senior Vice President, Pharmaceutical Marketing Division of Takeda. "We are continually striving to deliver innovative therapies as quickly as possible to patients in Japan."
|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 :
Anaplastic large cell lymphoma
Takeda's consolidated forecasts for fiscal 2014 will be announced on May 8, 2014.