EC grants conditional marketing authorisation for ADCETRIS to treat hematological cancers

Oct 31 2012

Takeda Pharmaceutical Company Limited (TSE:4502, "Takeda") and Millennium: The Takeda Oncology Company, today announced that the European Commission (EC) has granted conditional marketing authorisation for ADCETRIS^® (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).

“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.”

On 19 July 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for conditional marketing authorisation for brentuximab vedotin, based on a positive benefit-risk assessment in the above indications. Granting of conditional marketing authorisation by the EC means that there are specific obligations to provide additional clinical data at a later stage to confirm the positive benefit-risk balance.

Takeda intends to launch brentuximab vedotin across Europe, with the first launches planned in the coming weeks.

"Brentuximab vedotin has been shown to offer a high overall response rate, including durable complete responses in both of its indications," said Professor Andreas Engert, M.D., University Hospital of Cologne, Germany. "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."

"The European conditional marketing authorisation of brentuximab vedotin represents a significant step in Takeda's oncology franchise commitment to developing innovative medicines that make a real difference to patients' lives," said Trevor Smith, Head of Commercial Operations, Europe & Canada, Takeda Pharmaceuticals. "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."

Brentuximab vedotin is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL and sALCL. The marketing authorisation, which will be held by Takeda Global Research & Development Centre (Europe) Ltd, is valid in all EU member states as well as Iceland, Liechtenstein and Norway, and is based on data from clinical trials and other supportive data in relapsed or refractory HL and relapsed or refractory sALCL.