Approval After Phase I: Ceritinib Runs the Three-Minute Mile

Abstract

The FDA approval of ceritinib after its phase I trial marks the beginning of a new era of cancer drug development for industry, for its academic partners, and for patients. Cautions remain about dosing and side effects, but this is an important new drug, filling a void for crizotinib-resistant disease, and its accelerated approval after phase I is well justified.