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イハラ トシコ
Toshiko Ito-Ihara
猪原 登志子 所属 川崎医科大学 医学部 応用医学 先端医療開発学 職種 教授 |
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| 論文種別 | 原著 |
| 言語種別 | 英語 |
| 査読の有無 | 査読あり |
| 表題 | A Qualitative Study on the Differences Between Trial Populations and the Approved Therapeutic Indications of Antineoplastic Agents by 3 Regulatory Agencies From 2010 to 2018. |
| 掲載誌名 | 正式名：Clinical therapeutics 略 称：Clin Ther ISSNコード：1879114X/01492918 |
| 掲載区分 | 国外 |
| 巻・号・頁 | 42(2),pp.305-320.e0 |
| 著者・共著者 | Eriko Sumi, Ryuta Asada, Ying Lu, Toshiko Ito-Ihara, Kevin V Grimes |
| 発行年月 | 2020/02 |
| 概要 | PURPOSE:The present study aimed to examine the differences between enrolled subject populations and use of combination therapies as defined by the pivotal clinical trial protocols and the approved indications of anticancer drugs as determined by 3 major regulatory agencies.METHODS:Thirty-eight approvals were collected that received market authorization from the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Pharmaceuticals and Medical Devices Agency (PMDA) between January 2010 and September 2018 for initial approval of an anticancer drug or for an expanded therapeutic indication for a previously approved anticancer drug, based on the same pivotal clinical trial(s). The subject eligibility criteria of the pivotal clinical trials and the approved indications as established by these agencies were compared, and the differences were categorized according to patient biomarkers status, prior treatment status, and the use of combination therapies.FINDINGS:In 20 (53%) approvals, there was a discrepancy between biomarker status of enrolled subjects in the pivotal trial and the therapeutic indication. In 7 of these cases, the biomarkers were used to diagnose the target cancer or to stratify the study subjects in the pivotal trial. In 9 cases, the biomarker discrepancies were related to minor histologic subtypes of the target cancer. Regarding prior treatment status, the FDA and the EMA generally approved indications for the same treatment line as the pivotal trials, whereas the PMDA did not restrict approval to untreated patients when the pivotal trial included only treatment-naive subjects. In 14 approvals, the FDA and the EMA designated the same co-administered drugs as part of the approved indications in line with the pivotal trials. However, the PMDA did not specify the co-administered drugs in 2 approvals and did not require combination therapy in 1 case.IMPLICATIONS:In principle, the approved therapeutic indications should be determin |
| DOI | 10.1016/j.clinthera.2020.01.002 |
| PMID | 32008723 |