Takeda Pharmaceutical Company and Millennium: The Takeda Oncology Company have won European conditional marketing authorization for Adcetris (brentuximab vedotin).
Adcetris is indicated for use in adult patients with relapsed or refractory CD30 positive Hodgkin lymphoma (HL) or relapsed or refractory systemic anaplastic large cell lymphoma (sALCL).
The company expects to launch the antibody-drug conjugate across Europe shortly.
University Hospital of Cologne, Germany Professor Andreas Engert said, "Conditional marketing authorisation by the European Commission signifies an important advancement in the treatment of adult patients with these rare CD30 positive hematological cancers who are relapsed or refractory and previously had limited options."
Adcetris is used for relapsed or refractory CD30 positive HL patients who underwent an autologous stem cell transplant or received any other prior therapies.
Marketing authorization approval is based on clinical trial data and other supportive data from trials conducted in relapsed or refractory HL and relapsed or refractory sALCL.
Takeda Pharmaceuticals Europe and Canada commercial operations head Trevor Smith said, "Brentuximab vedotin is a new targeted therapeutic option for adult patients with relapsed or refractory Hodgkin lymphoma or relapsed or refractory systemic anaplastic large cell lymphoma, and Takeda looks forward to making it available in Europe."