Adcetris Given Market Approval in Japan


The first in class antibody drug conjugate will now be available to residents of Japan with two subtypes of lymphoma.

The business collaborator with Seattle Genetics, Takeda Pharmaceutical Company Limited (Takeda), has announced that they have been given approval for Adcetris (brentuximab vedotin) from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of patients with CD30-positive, relapsed or refractory Hodgkin's lymphoma (HL) and anaplastic large cell lymphoma (ALCL).

In a statement, Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics, said:

Until now, patients in Japan with relapsed or refractory Hodgkin lymphoma or ALCL had few therapeutic treatment options, and the approval of Adcetris represents a significant milestone in making this innovative targeted therapy available to these patients in need. Adcetris is now approved in 39 countries, and we continue to work with our collaborator, Takeda, to expand regulatory approvals globally. Through both our regulatory activities and robust clinical development program, our goal is to establish Adcetris as the foundation of therapy worldwide for patients with CD30-positive malignancies.

The Japanese Ministry of Health, Labour and Welfare decided to approve the therapy based on two global pivotal phase II clinical trials, along with one phase I/II trial carried out in Japan among patients with relapsed or refractory CD30-positive HL and ALCL.

Source: Seattle Genetics

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