Wednesday, October 31, 2012

Takeda and Millennium Announce European Conditional Marketing Authorisation for ADCETRIS® (Brentuximab Vedotin)


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). 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. Brentuximab vedotin is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL and sALCL. 

Millenium got Adcetris, from Seattle in December 2009 and Millennium will now pay Seattle Genetics  $25 million in milestone payments and a tiered double-digit percentage royalty on European sales.

The price of Adcetris in the US is about $13,500, which equates to around $108.000 per patient assuming an average dosing of 8. While if If a patient gets the maximum number of 16 doses described in the FDA-approved label, it will cost $216,000 per patient.

In clinical trials, Adcetris was able to significantly shrink tumors in about 75 percent of patients with Hodgkin’s disease, and in about 86 percent of patients with anaplastic large cell lymphoma (ALCL).

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