抗癌药物风险评估和风险降低计划的现状分析

Risk Evaluation and Mitigation Strategy in Oncology Products

目的对美国FDA关于抗癌药物的风险评估和风险降低计划(REMS)的实施现状和特点进行综述和分析。方法根据FDA对药物实行风险评估和风险降低计划的要求,跟踪查阅有关抗癌药物风险评估和风险降低计划的实施和撤销情况,分析探讨抗癌新药风险降低的动态管理。结果风险评估和风险降低计划是FDA为确保临床药品的安全使用而制订的文件,虽然多数抗癌药物的风险评估和风险降低计划包含复杂内容,但抗癌药物风险评估和风险降低计划的实施比例并不比非抗癌药物高很多,这主要是由于癌症及其治疗的特殊性所决定,肿瘤临床的多环节协调把关以及新型靶位治疗药物对癌细胞的特异性和选择性在一定程度上降低了实施风险评估和风险降低计划的必要性。结论风险评估和风险降低计划文件在促进新药研发和保证治疗安全有效方面发挥了积极作用,其制订实施需要根据不同药物的特性和临床中出现的新问题而定。

OBJECTIVE To review and analyze the specificity and dynamic changes in developing the Risk Evaluation and Miti- gation Strategy （REMS） in oncology products. METHODS Based on FDA＇s requirement for REMS for some high-risk drugs and bio- logics, 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.