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About the Speaker

Nicholas Richardson, DO, MPH and Yvette Kasamon, MD
Clinical Team Leader
Division of Hematologic Malignancies II (DHM II)
Office of Oncologic Diseases (OOD)
Food & Drug Administration (FDA)

Nicholas C. Richardson DO, MPH, is a Clinical Team Leader in the Division of Hematologic Malignancies II within the Office of Oncologic Diseases, at the Food and Drug Administration (FDA). Prior to joining the FDA, he completed his pediatric residency and chief residency at A.I. duPont Hospital for Children/Thomas Jefferson University and fellowship in pediatric hematology and oncology at Vanderbilt University Medical Center. Dr. Richardson’s clinical and regulatory interest include Hodgkin and non-Hodgkin lymphoma, clinical utilization of minimal residual disease, pediatric drug development in oncology, innovative clinical trial designs including master protocols, and patient advocate engagement.

Yvette Kasamon, MD, is a clinical team leader in the Division of Hematologic Malignancies II within the Office of Oncologic Diseases at the FDA. Before joining the FDA in 2015, she completed an internal medicine residency at the Brigham and Women’s Hospital and a hematology-oncology fellowship at Johns Hopkins University, then joining its faculty as a clinical investigator with a focus on lymphoma. Dr. Kasamon’s clinical and regulatory interests include Hodgkin lymphoma, non-Hodgkin lymphoma, and CLL. She remains an Adjunct Associate Professor of Oncology at Johns Hopkins.

About the Presentation

Several drugs called phosphatidylinositol 3-kinase or PI3K inhibitors have been FDA approved for patients with chronic lymphocytic leukemia (CLL), a cancer of the blood, and certain types of lymphoma, a cancer of the immune system, such as follicular lymphoma (FL) and marginal zone lymphoma (MZL). The PI3K inhibitor drug class is associated with notable side effects that can be serious or fatal, including infection, diarrhea, liver problems, rash, and inflammation of the lungs. There are clinical trials showing concerns with survival in patients with CLL or lymphoma because of the serious side effects of the PI3K inhibitor drug class. Information on the PI3K inhibitor drug class will be discussed and how it impacts future PI3K inhibitors developed for patients with cancer. Broader considerations in clinical trial design and endpoints for cancer drugs will be discussed, using this drug class as an example.

Learning Objectives

1. Identify the side effects associated with the PI3K inhibitor drug class, and how these may impact outcomes such as overall survival.
2. Describe the differences in information gained from randomized controlled trials and single-arm trials of cancer drugs.
3. Evaluate how the information from a class of products for cancer should impact future development of products in the same class.

Webcast Recording: https://fda.zoomgov.com/rec/share/R-02Hi-fXCzTuCKoXAANgfb8MUzXpGW-mc6qb0Ao2fAWhzkEo8s_5pJlAb4cV3rk.YEutL4yt5xUgcu7u

 

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