Abstract
美国、欧洲、日本、中国相继出台政策鼓励孤儿药的研发，大量孤儿药获批上市，罕见肿瘤药物是其中重要的组成部分。孤儿药政策有力推动了罕见肿瘤新药的研发，也使得众多已获批药物的潜能被充分挖掘，并有望革新肿瘤及肿瘤药物分类观念。但是长达7年的市场独占期、政策的经济支持、低标准的上市前临床试验也使得罕见肿瘤药物存在定价、安全性、有效性等一系列问题，亟需更多医疗工作者的努力。.
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