News Feature | January 21, 2014

Takeda's Lymphoma Drug Adcetris NDA Wins Approval In Japan

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By Estel Grace Masangkay

Takeda Pharmaceutical’s new drug application (NDA) for its lymphoma drug Adcetris (brentuximab vedotin) has been approved by the Japanese Ministry of Health, Labor, and Welfare.

Adcetris is an antibody drug conjugate (ADC) available in 50 mg powder for concentrate for solution infusion. It is used to treat patients with lymphoma in the form of relapsed/refractory anaplastic large cell lymphoma (ALCL) following autologous stem cell transplant (ASCT) or following at least two prior treatments (not including ASCT/multi-agent chemotherapy). Adcetris is also indicated in CD30 positive relapsed/refractory Hodgkin’s lymphoma (HL). The drug constitutes an anti-CD30 monoclonal antibody.

Adcetris makes use of a linker system proved to be stable in the bloodstream. Using technology from Seattle Genetics, the antibody is attached by a protease-cleavable linker to a monomethyl auristatin E (MMAE), a microtubule disrupting agent. MMAE is then released once it has been internalized into the CD30-expressing tumor cells.

Seattle Genetics CEO and President Clay B. Siegall 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.”

The ministry based the drug’s NDA approval on its Phase I/II clinical trial results in patients with relapsed or refractory CD30-positive HL, as well as those with CD30-positive systemic ALCL. The results also included data from two global Phase II Adcetris clinical trials.

Takeda Oncology Therapeutic Area Unit head 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.”

The Japanese Ministry of Health, Labor, and Welfare has already granted Takeda orphan drug status for Adcetris in March last year. The drug was targeted for priority review in the country for treatment of patients with HL and ALCL.

Source:

http://www.takeda.com/news/2014/20140117_6153.html

http://regulatoryaffairs.pharmaceutical-business-review.com/news/takedas-nda-of-lymphoma-drug-adcetris-50mg-gets-approval-in-japan-200114-4161768

http://www.biospectrumasia.com/biospectrum/regulatory/207079/takeda-receives-japanese-nod-adcetris#.Ut6TbrROnIV

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