Gainor Justin F, Chabner Bruce A
Massachusetts General Hospital, Boston, Massachusetts, USA.
Massachusetts General Hospital, Boston, Massachusetts, USA
Oncologist. 2015 Aug;20(8):847-8. doi: 10.1634/theoncologist.2015-0253. Epub 2015 Jul 14.
“Accelerated Approval” (AA) has addressed important unmet needs in oncology. However, it is only justified if the drug fills a serious gap because such approval entails risk and leads to marketing based on incomplete information about toxicity, dose, and therapeutic potential. Furthermore, the policy of requiring companion diagnostics for AA of drugs that target specific mutations needs further discussion.
“加速批准”(AA)解决了肿瘤学领域一些重要的未满足需求。然而,只有当药物填补了严重空白时,这种批准才是合理的,因为这种批准存在风险,并且会基于关于毒性、剂量和治疗潜力的不完整信息进行上市推广。此外,针对靶向特定突变的药物加速批准要求配套诊断的政策需要进一步讨论。