Risk Evaluation and Mitigation Strategies (REMS) for oral oncolytics: Increased safety or barrier to access?
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.
Authors
- Vincent Dormer Harris (ORCID: https://orcid.org/0000-0002-6589-2957)
- M Tai
Institutions
- The Barbara Ann Karmanos Cancer Institute (US)
- Levine Cancer Institute (US)
Publication Details
- Journal
- Journal of Oncology Pharmacy Practice
- Published
- 2025-09-16
- DOI
- https://doi.org/10.1177/10781552251377770
- Primary Topic
- Virus-based gene therapy research
- Type
- article
- Field-Weighted Citation Impact
- 0.00