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The FDA Grand Rounds is an educational presentation that is webcast monthly to highlight cutting-edge research underway across the Agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities. The 45-minute educational presentation is followed by questions from the audience. You can also view the presentation under Past Grand Rounds following the live webcast. #FDAGrandRounds.

The Saga of Phosphatidylinositol 3-Kinase (PI3K) Inhibitors

Thursday, May 12, 2022
12:00 p.m. - 1:00 p.m. EST

About the Speakers

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.

For technical assistance please contact: Madison.Hanson@fda.hhs.gov

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