A Significant Anticancer Drug Approval Lag Between Japan and the United States Still Exists for Minor Cancers
A Significant Anticancer Drug Approval Lag Between Japan and the United States Still Exists for Minor Cancers
复制标题
DOI：
10.1002/cpt.1136
复制
发表时间：
2019-01-01
影响因子：
6.7
通讯作者：
Narukawa, Mamoru
中科院分区：
文献类型：
--
作者：
Yamashita, Kenji;Kaneko, Masayuki;Narukawa, Mamoru
报告指出，日本和美国之间抗癌药物的批准滞后已经减少。然而，用于治疗轻微癌症的药物是否也是如此仍然未知。我们分析了2006年至2016年在日本批准的抗癌药物，以比较日本和美国之间基于癌症发病率（主要与次要癌症）的药物批准滞后。与十年前相比，针对小癌症的抗癌药物的滞后并没有减少。最近，制药公司更多地使用导致更长批准延迟的开发策略来开发用于治疗轻微癌症的药物，而不是针对主要癌症的药物，导致主要癌症和轻微癌症药物之间的批准延迟时间存在显着差异。因此，应该采取有效措施，加快日本针对小癌症的药物开发，以缩短滞后时间。
Reports have indicated that approval lag for anticancer drugs between Japan and the United States has decreased. However, if this is also true for drugs used to treat minor cancers remains unknown. We analyzed the anticancer drugs approved in Japan from 2006 to 2016 to compare the drug approval lag based on cancer incidence (major vs. minor cancers) between Japan and the United States. The lag of anticancer drugs for minor cancers had not decreased relative to that a decade ago. Recently, development strategies resulting in longer approval lag were used by pharmaceutical companies more often for the development of drugs used to treat minor cancers than for drugs targeting major cancers, leading to significant differences in the approval lag time between drugs for major and minor cancers. Effective measures that expedite the development of drugs targeting minor cancers in Japan should, therefore, be implemented to shorten lag time.