FDA's ODAC votes unanimously that future PI3K inhibitors should include randomized data for blood cancers

A panel of FDA’s outside advisors unanimously voted, with one abstention, that future approvals of PI3K inhibitors should be supported by randomized data.

The 17-member ODAC panel was asked by federal regulators to discuss observed toxicities of the Phosphatidylinositol-3-kinase inhibitor class and whether randomized survival data are needed to support risk-benefit evaluations in patients with blood cancers. They returned, after listening to agency presenters, with a resounding “Yes.”