Takeda Pharmaceutical Company Limited together with its wholly-owned subsidiary Millennium: The Takeda Oncology Company, announced that the European Medicines Agency (EMA) has accepted the filing of the Marketing Authorization Application (MAA) for Adcetris (brentuximab vedotin) for the treatment of relapsed or refractory Hodgkin lymphoma (HL) and relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). The MAA was filed by Takeda Global Research & Development Centre (Europe). Acceptance of the MAA confirms that the submission is sufficiently complete to permit a substantive review.
“This filing brings us a step closer to providing a new treatment option to patients in the European Union with relapsed or refractory HL and relapsed or refractory sALCL — two areas of unmet medical need,” said Nancy Simonian, M.D., chief medical officer, Millennium. “We look forward to working with the EMA on this submission.”
The MAA contains data from pivotal phase II studies in relapsed or refractory Hodgkin lymphoma and relapsed or refractory sALCL. Top line results from these studies were presented at the 52nd American Society of Hematology (ASH) Annual Meeting in December 2010.
In January 2009 Adcetris received orphan product designations for the treatment of patients with HL and sALCL in the European Union from the Committee for Orphan Medicinal Products (COMP). Orphan medicinal product designation is conferred upon products for diseases that affect no more than 5 in 10,000 people in the EU at the time of the submission.
Adcetris (brentuximab vedotin) is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a potent, synthetic drug, 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 approach allows for the selective targeting of CD30-expressing cancer cells.
Seattle Genetics is jointly developing Adcetris with Millennium: The Takeda Oncology Company. Under the terms of the collaboration agreement, Seattle Genetics has US and Canadian commercialization rights and the Takeda Group has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and the Takeda Group are funding joint development costs for Adcetris on a 50:50 basis, except in Japan where the Takeda Group will be solely responsible for development costs.
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine.
Millennium: The Takeda Oncology Company, a leading biopharmaceutical company based in Cambridge, Mass., markets Velcade, a first-in-class proteasome inhibitor, and has a robust clinical development pipeline of product candidates. Millennium Pharmaceuticals, Inc. was acquired by Takeda Pharmaceutical Company Ltd. in May, 2008.