Risk Evaluation and Mitigation Strategies (REMS) for oral oncolytics: Increased safety or barrier to access?

Abstract

Many oral oncolytics inhibit rapidly dividing cells and are teratogenic. However, only a few agents are restricted under a Risk Evaluation and Mitigation Strategies (REMS) program due to embryo-fetal toxicity. The benefit of a REMS program for only select oral oncolytics is unclear.