Asian Scientist (Jan. 21, 2014) – The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Takeda Pharmaceutical Company’s new drug application using ADCETRIS® (brentuximab vedotin) for the treatment of patients with certain types of lymphoma.
The application approval was based on data from two global phase 2 trials as well as a phase 1/2 clinical trial in Japanese patients with relapsed or refractory CD30-positive Hodgkin’s lymphoma (HL) and patients with relapsed or refractory CD30-positive systemic anaplastic large cell lymphoma (ALCL).
ADCETRIS had been granted orphan drug designation by the MHLW for treatment of patients with HL and ALCL in March 2012, thereby accelerating the review of its application as a new drug 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). 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 Dr Michael Vasconcelles, Head of the Oncology Therapeutic Area Unit.
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