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news.The European Medicines Agency (EMA) has accepted Takeda Pharmaceutical and Millennium: The Takeda Oncology Company's marketing authorization application (MAA) for antibody-drug conjugate (ADC) Adcetris (brentuximab vedotin).
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Adcetris MAA was filed as a treatment for relapsed or refractory Hodgkin lymphoma (HL) and relapsed or refractory systemic anaplastic large cell lymphoma (sALCL) by Takeda Global Research & Development Centre (Europe).
Takeda‘s MAA for Adcetris was supported by the results of Phase II studies in relapsed or refractory Hodgkin lymphoma and relapsed or refractory sALCL.
Millennium chief medical officer Nancy Simonian said this filing brings them 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.
"We look forward to working with the EMA on this submission," Simonian said.