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.

Keywords

REMS lenalidomide thalidomide pomalidomide FDA

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