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Oct 31, 2012

EC Conditionally Sanctions Lymphoma Treatment

  • The EC granted conditional approval for Seattle Genetics and Millennium’s antibody-drug conjugate (ADC) Adcetris (brentuximab vedotin) for two indications: the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma (HL) either after autologous stem cell transplant (ASCT) or after at least two prior therapies when ASCT or chemotherapy aren’t appropriate; and for treating adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). Each approval has triggered a $25 million milestone payment to Seattle.

    Adcetris is an ADC comprising an anti-CD30 monoclonal antibody attached to a cytotoxic microtubule disrupting agent monomethyl autistatin E, using Seattle’s linker technology. The drug was granted accelerated approval by FDA for the relapsed HL and sALCL indications in August 2011. Similar to accelerated approval regulations in the U.S., the EC’s conditional marketing authorization requires that Seattle and Millennium provide additional clinical data in the future to confirm the positive benefit-risk assessment of the drug.

    Under terms of Seattle and Millennium’s partnership for Adcetris, which they signed back in 2009, Seattle retains U.S. and commercialization rights and Millenium’s now parent, Takeda, retains rights to commercialize the drug in the rest of the world. The firms are funding development costs on a 50:50 basis, except in Japan, which remains Takeda’s responsibility.

    Within the last 10 days Seattle announced expanding an ongoing ADC collaboration with Abbott, to include additional targets. The expanded deal could earn Seattle up to another $220 million in milestones, in addition to its $25 million up-front fee.

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