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.
On Sept. 24, 2002, when I showed up at a meeting of the FDA Oncologic Drugs Advisory Committee, I had a pretty good idea that the drug on the agenda—AstraZeneca’s Iressa (gefitinib)—was having a surprising effect on some patients in third-line non-small cell lung cancer.
