Brentuximab Vedotin (Adcetris) for Treating Recurrent or Refractory Hodgkin's Lymphoma

May 14, 2012 | Technology Forecasts

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Patients with a history of Hodgkin's lymphoma (HL) often experience disease recurrence, and in many cases the disease becomes resistant to first-line treatments such as chemotherapy, radiation, autologous stem cell transplantation, and combined modalities.1 This has resulted in increased demand for new therapeutic options that can prevent or inhibit the growth of recurring tumors.

Seattle Genetics (Bothell, WA, USA), in collaboration with Millennium Pharmaceuticals (Cambridge, MA, USA), has developed brentuximab vedotin (Adcetris),2 an antibody-drug conjugate intended to treat patients with recurrent or refractory HL whose disease has failed to respond to previous first-line treatments. Adcetris targets CD30, a defining marker of HL and systemic anaplastic large cell lymphoma (ALCL).3 The drug comprises an anti-CD30 monoclonal antibody linked to a cell-killing agent, monomethyl auristatin E.2 CD30 is a member of the tumor necrosis factor receptor super-family and is highly expressed on Hodgkin's Reed-Sternberg cells.4 It is also expressed on active B- and T-lymphocytes and natural killer cells but is rarely present on nonmalignant cells.5 These attributes have made CD30 an attractive target for an immunotherapeutic approach with antibody-drug conjugate.

Seattle Genetics has commercialization rights to Adcetris in the United States and Canada, while Millennium has exclusive rights to commercialize the product throughout the rest of the world.6

On August 19, 2011, the U.S. Food and Drug Administration (FDA) approved Adcetris for marketing under the accelerated approval program to treat HL and systemic ALCL.3 The approval was intended to provide patients with access to treatment for their serious disease based on promising clinical data that suggest Adcetris may provide a clinical benefit. Adcetris is the first treatment FDA approved for HL since 1977 and the first product specifically indicated to treat ALCL.3 Under the accelerated approval program, Seattle Genetics will be required to...

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