Reverse Translation of US Food and Drug Administration Reviews of Oncology New Molecular Entities Approved in 2011–2017: Lessons Learned for Anticancer Drug Development

We conducted a comprehensive analysis of clinical pharmacology evaluations in initial submissions of 56 oncology new molecular entities approved by the US Food and Drug Administration between January 2011 and April 2017. Results from studies evaluating food effect, QTc prolongation, drug-drug interactions, renal and hepatic impairment effects, and dose optimization, as well as postmarketing requirements/commitments, were reviewed. This reverse translational research highlights the importance of clinical pharmacology and pharmacometrics in benefit-risk characterization, regulatory review, and labeling of anticancer therapeutics.