Seattle Genetics Receives $5 Million Milestone Payment for Brentuximab Vedotin

Seattle Genetics has announced that it will receive a $5 million milestone payment from Millennium: The Takeda Oncology Company under their collaboration agreement for brentuximab vedotin (ADCETRIS), a therapy for the treatment of relapsed or refractory Hodgkin lymphoma and relapsed or refractory systemic anaplastic large cell lymphoma (ALCL). This milestone was triggered by the European Medicines Agency (EMA) acceptance of the Marketing Authorization Application (MAA) for brentuximab vedotin. The therapy is an antibody-drug conjugate (ADC) directed to CD30, the defining marker of Hodgkin lymphoma and ALCL.

Key Takeaways:

  • Seattle Genetics will receive a $5 million milestone payment from Millennium: The Takeda Oncology Company under their collaboration agreement for brentuximab vedotin.
  • The milestone was triggered by the European Medicines Agency (EMA) acceptance of the Marketing Authorization Application (MAA) for brentuximab vedotin.
  • Brentuximab vedotin is an antibody-drug conjugate (ADC) directed to CD30, the defining marker of Hodgkin lymphoma and ALCL.
  • The therapy is being developed in collaboration with Millennium: The Takeda Oncology Company for the treatment of relapsed or refractory Hodgkin lymphoma and relapsed or refractory systemic ALCL.
  • Seattle Genetics has also received priority review from the FDA for its Biologics License Applications for brentuximab vedotin, with a PDUFA date of August 30, 2011.
  • Brentuximab vedotin is being evaluated in multiple ongoing clinical trials, including a phase III study for patients at high risk of residual Hodgkin lymphoma following autologous stem cell transplant (ASCT).
  • Seattle Genetics is a clinical-stage biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer and autoimmune disease.

Statistics:

  • 8,800 cases of Hodgkin lymphoma are expected to be diagnosed in the United States in 2011.
  • 1,300 people are expected to die from Hodgkin lymphoma in the United States in 2011.
  • Brentuximab vedotin has been evaluated in a pivotal trial in relapsed or refractory Hodgkin lymphoma and a phase II trial in relapsed or refractory systemic ALCL.
  • The FDA has accepted for filing two Biologics License Applications (BLAs) for brentuximab vedotin.
  • The FDA's Oncologic Drugs Advisory Committee will review the BLAs for brentuximab vedotin on July 14, 2011.
  • The action date for the BLAs is August 30, 2011 under the Prescription Drug User Fee Act.

Sources:

  • Seattle Genetics, "Seattle Genetics to Receive $5 Million Milestone Payment from Millennium: The Takeda Oncology Company," [www.seattlegenetics.com](http://www.seattlegenetics.com).
  • American Cancer Society, "Hodgkin Lymphoma Facts," [www.cancer.org](http://www.cancer.org).
  • Seattle Genetics, "Brentuximab Vedotin," [www.seattlegenetics.com](http://www.seattlegenetics.com).
  • FDA, "Brentuximab Vedotin (ADCETRIS)," [www.fda.gov](http://www.fda.gov).