Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited (TSE:4502) today 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 E.U. at the time of the submission.
Source: Millennium: The Takeda Oncology Company