The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Takeda Pharmaceutical's new drug application (NDA) of Adcetris (brentuximab vedotin) 50mg intended to treat patients with CD30 positive relapsed or refractory hodgkin lymphoma (HL) or relapsed or refractory anaplastic large cell lymphoma (ALCL).
The NDA approval was based on a Phase I/II clinical trial in patients with relapsed or refractory CD30-positive HL and patients with relapsed or refractory CD30-positive systemic ALCL, as well as data from two global Phase II clinical trials.
MHLW also granted orphan drug status to Adcetris in March 2012 for the treatment of patients with HL and ALCL, and therefore was targeted for priority review in Japan.
Adcetris, an antibody-drug conjugate (ADC), comprises an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), using Seattle Genetics' technology.
The ADC uses a linker system designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.
Takeda head of the Oncology Therapeutic Area Unit Michael Vasconcelles said, "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."