FDA Public Workshop: Assessment of Cardiovascular Toxicities in Immuno-oncology Trials
On Friday, December 1, 2017, the U.S. Food & Drug Administration (FDA) announced a public workshop entitled, “Assessment of Cardiovascular Toxicities in Immuno-oncology Trials”. This workshop provided a forum for discussion of cardiovascular toxicities in immuno-oncology clinical trials. The workshop focused on the identification of best practices to assess cardiovascular and metabolic toxicities in patients receiving cancer immunotherapies. The session was done in collaboration with Oncology Center of Excellence (OCE)
with support from the American Association for Cancer Research (AACR), American College of Cardiology (ACC), American Heart Association (AHA), & American Society of Clinical Oncology (ASCO)
Drs. Laleh Amiri-Kordestani (FDA) and Javid Moslehi (Vanderbilt) co-organized the meeting and brought together cardiologists, oncologists, immunologist, basic and clinical scientists with expertise on adverse effects of immunotherapies but particularly patients who suffer from myocarditis and arrhythmias following treatment with immune checkpoint inhibitors.