ASH/FDA Update on Nivolumab

8/9/2016

Description

This webinar discusses the FDA accelerated approval of nivolumab for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin. The approval was based on two single-arm, multicenter trials of nivolumab in adults with relapsed or refractory cHL. The trials enrolled patients regardless of PD-L1 expression status on Reed-Sternberg cells. The primary efficacy endpoint was objective response rate (ORR) as determined by an independent radiographic review committee. Additional outcome measures included duration of response (DOR).

Speakers

  • Wyndham Wilson, MD, PhD, Center for Cancer Research, National Cancer Institute, Bethesda, MD
  • Yvette L. Kasamon, MD, Division of Hematology Products, Office of Hematology and Oncology Products, U.S. Food and Drug Administration, Silver Spring, MD
  • Stephen Ansell, MD, PhD, Professor of Medicine, Chair, Lymphoma Group, Mayo Clinic, Rochester, MN

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