Morita Tomohiro, Hori Akiko, Narimatatsu Hiroto, Tanimoto Tetsuya, Kami Masahiro
Division of Exploratory Research, The Institute of Medical Science, The University of Tokyo, 4-6-1, Shirokanedai, Minato-ku, Tokyo, 108-8639, Japan.
First Outpatient Division, The National Cancer Center Hospital, Tokyo, Japan.
Int J Hematol. 2008 Jun;87(5):484-489. doi: 10.1007/s12185-008-0087-2. Epub 2008 Apr 29.
To investigate the current status of the development of anticancer agents in Japan, we examined the number of these agents developed after 1999, their target diseases, and the association between the number of approved agents and the number of patients with the diseases. The data were obtained via the Internet. Of the 487 agents approved from 1999 to April 2007, 84 were anticancer drugs. Of these 84, 46 were approved based on clinical trials and 38 were approved through the new drug application for off-label usages without clinical trials. The target diseases of the 46 agents approved through clinical trials were nonhematologic tumors in 29, hematologic malignancies in 13, and others in 4. Of the 38 approved through the new drug application for off-label usages, 31 were for nonhematologic tumors and 7 for hematologic malignancies. The number of approved anticancer agents for hematologic malignancies per unit patient population was 6.5-times as many as that for nonhematologic tumors. This study demonstrated that the situation regarding the development of anticancer agents differs among tumor types. The majority of anticancer agents developed target hematologic malignancies, while the newly developed anticancer agents have affected treatment strategies for solid tumors.
为了调查日本抗癌药物的研发现状，我们研究了1999年后研发的此类药物数量、其靶向疾病，以及获批药物数量与患病人数之间的关联。数据通过互联网获取。在1999年至2007年4月获批的487种药物中，有84种是抗癌药物。在这84种药物中，46种是基于临床试验获批的，38种是通过新药申请获批用于未进行临床试验的非标签用途。通过临床试验获批的46种药物的靶向疾病中，29种是非血液系统肿瘤，13种是血液系统恶性肿瘤，4种是其他疾病。在通过新药申请获批用于非标签用途的38种药物中，31种用于非血液系统肿瘤，7种用于血液系统恶性肿瘤。每单位患者群体中获批的血液系统恶性肿瘤抗癌药物数量是非血液系统肿瘤的6.5倍。这项研究表明，抗癌药物的研发情况因肿瘤类型而异。大多数研发的抗癌药物靶向血液系统恶性肿瘤，而新研发的抗癌药物已经影响了实体瘤的治疗策略。
