On April 21, the FDA Oncologic Drugs Advisory Committee voted unanimously—with 16 “yes” votes and one abstention—to affirm that randomized data are warranted with an assessment of overall survival to support the evaluation of benefit-risk of phosphoinositide 3-kinase (PI3K) inhibitors in patients with hematologic malignancies.
Rick Pazdur, MD, the newly appointed director for the Center for Drug Evaluation and Research at the FDA, has been described as “greyhound thin” as a result of his dedication to cycling and lifting weights in the gym each day and, for a long time, a vegetarian diet. I first met him when he was the director of the Office of Oncology Drug Products (ODP) within CDER, in 2009.
