Millennium: The Takeda Oncology Company and Takeda Pharmaceutical Co. Ltd. (TKDG.DE) Announce Positive CHMP Opinion for Conditional Approval of ADCETRIS® (brentuximab vedotin) in Europe
7/20/2012 9:56:24 AM
CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE)--Millennium: The Takeda Oncology Company and, Takeda Pharmaceutical Company Limited (TSE:4502, “Takeda”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for conditional approval of brentuximab vedotin for two indications: (1) the treatment of adult patients with relapsed or refractory CD30 positive Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and (2) for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). Brentuximab vedotin is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL and sALCL. The CHMP opinion is based on data from clinical trials and other supportive data in relapsed or refractory HL and relapsed or refractory sALCL.