ABSTRACT
OBJECTIVE: To review and analyze the specificity and dynamic changes in developing the Risk Evaluation and Mitigation Strategy (REMS) in oncology products. METHODS: Based on FDA's requirement for REMS for some high-risk drugs and biologics, the REMS literatures of oncology products were tracked and accessed. The approved and released REMS programs of anti-cancer drugs were summarized and analyzed. RESULTS: REMS is a key tool for FDA to help manage and ensure the safe use of the medications. Though a disproportionate number of drugs with complex REMS are required in patients with cancer, the percentage of the oncology drugs with REMS requirement is not much higher than non-oncology products. This mainly resulted from the specificity of cancer and chemotherapy, in which much collaborative interaction among health care practitioners as well as the emerging target therapy with highly specificity and selectivity may contribute to minimize risk from medications.CONCLUSION: The necessity of developing REMS for an oncology product depends on its properties and the new circumstances in oncology practice.