{"title":"瑞士监管机构 Swissmedic 的决策，重点关注（新）辅助癌症治疗。","authors":"Matea Pavic, Qiyu Li, Stephanie Juritz, Arunas Gircys, Anita Wolfer, Ulrich-Peter Rohr","doi":"10.1159/000536541","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Additional considerations are required for the benefit-risk assessment of new drugs or indications in the setting of (neo)adjuvant cancer treatment as compared to the metastatic/advanced setting, possibly leading to different decision patterns for the (neo)adjuvant versus the metastatic and advanced setting within a health authority but also among different health authorities.</p><p><strong>Methods: </strong>We analyzed regulatory decisions at the Swiss Agency for Therapeutic Products Swissmedic (SMC) for all oncology indications (mostly metastatic indications) and indications in the (neo)adjuvant setting and compared these to decisions taken by the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA).</p><p><strong>Results: </strong>Comparing the positive and negative decisions within the Swiss Agency for Therapeutic Products Swissmedic (SMC) between July 2017 and Dec 2021 the approval rates were with 66.7% lower for (neo)adjuvant indications versus 88.4% in the metastatic and advanced indications. While the approval rates for metastatic and advanced New Active Substances (NAS) applications were similar at SMC as compared to the EMA and the FDA, they were lower for (neo)adjuvant applications at SMC as compared to the EMA and the FDA. The underlying reason in all cases with divergent decisions at SMC as compared to EMA and FDA was that no overall survival (OS) benefit as compared to control arm has been observed in the submitted data package.</p><p><strong>Conclusion: </strong>Approval and consensus decision rates at SMC in comparison to EMA and FDA were lower for (neo)adjuvant indications but not for advanced and metastastic NAS oncology indications.</p>","PeriodicalId":19497,"journal":{"name":"Oncology","volume":null,"pages":null},"PeriodicalIF":2.5000,"publicationDate":"2024-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Decision-making at Swissmedic, the Swiss regulatory agency, with a focus on (neo)adjuvant cancer treatments.\",\"authors\":\"Matea Pavic, Qiyu Li, Stephanie Juritz, Arunas Gircys, Anita Wolfer, Ulrich-Peter Rohr\",\"doi\":\"10.1159/000536541\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Additional considerations are required for the benefit-risk assessment of new drugs or indications in the setting of (neo)adjuvant cancer treatment as compared to the metastatic/advanced setting, possibly leading to different decision patterns for the (neo)adjuvant versus the metastatic and advanced setting within a health authority but also among different health authorities.</p><p><strong>Methods: </strong>We analyzed regulatory decisions at the Swiss Agency for Therapeutic Products Swissmedic (SMC) for all oncology indications (mostly metastatic indications) and indications in the (neo)adjuvant setting and compared these to decisions taken by the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA).</p><p><strong>Results: </strong>Comparing the positive and negative decisions within the Swiss Agency for Therapeutic Products Swissmedic (SMC) between July 2017 and Dec 2021 the approval rates were with 66.7% lower for (neo)adjuvant indications versus 88.4% in the metastatic and advanced indications. While the approval rates for metastatic and advanced New Active Substances (NAS) applications were similar at SMC as compared to the EMA and the FDA, they were lower for (neo)adjuvant applications at SMC as compared to the EMA and the FDA. The underlying reason in all cases with divergent decisions at SMC as compared to EMA and FDA was that no overall survival (OS) benefit as compared to control arm has been observed in the submitted data package.</p><p><strong>Conclusion: </strong>Approval and consensus decision rates at SMC in comparison to EMA and FDA were lower for (neo)adjuvant indications but not for advanced and metastastic NAS oncology indications.</p>\",\"PeriodicalId\":19497,\"journal\":{\"name\":\"Oncology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.5000,\"publicationDate\":\"2024-03-05\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1159/000536541\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1159/000536541","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
导言：与癌症转移/晚期治疗相比，在癌症（新）辅助治疗情况下对新药或适应症进行效益-风险评估时需要考虑更多因素，这可能导致在一个卫生部门内部以及不同卫生部门之间，癌症（新）辅助治疗与癌症转移和晚期治疗的决策模式有所不同：我们分析了瑞士治疗产品管理局（SMC）针对所有肿瘤适应症（主要是转移性适应症）和（新）辅助治疗适应症做出的监管决定，并将这些决定与欧洲药品管理局（EMA）和美国食品药品管理局（FDA）做出的决定进行了比较：比较瑞士治疗产品管理局（SMC）在2017年7月至2021年12月期间做出的积极和消极决定，（新）辅助适应症的批准率比转移性和晚期适应症低66.7%，而转移性和晚期适应症的批准率为88.4%。虽然 SMC 的转移性和晚期新活性物质（NAS）申请批准率与 EMA 和 FDA 相似，但 SMC 的（新）辅助适应症申请批准率却低于 EMA 和 FDA。与 EMA 和 FDA 相比，SMC 的决定出现分歧的根本原因是，在提交的数据包中未观察到与对照组相比有总生存期（OS）获益：结论：与 EMA 和 FDA 相比，SMC 对（新）辅助适应症的批准率和一致决定率较低，但对晚期和转移性 NAS 肿瘤适应症的批准率和一致决定率较低。
Decision-making at Swissmedic, the Swiss regulatory agency, with a focus on (neo)adjuvant cancer treatments.
Introduction: Additional considerations are required for the benefit-risk assessment of new drugs or indications in the setting of (neo)adjuvant cancer treatment as compared to the metastatic/advanced setting, possibly leading to different decision patterns for the (neo)adjuvant versus the metastatic and advanced setting within a health authority but also among different health authorities.
Methods: We analyzed regulatory decisions at the Swiss Agency for Therapeutic Products Swissmedic (SMC) for all oncology indications (mostly metastatic indications) and indications in the (neo)adjuvant setting and compared these to decisions taken by the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA).
Results: Comparing the positive and negative decisions within the Swiss Agency for Therapeutic Products Swissmedic (SMC) between July 2017 and Dec 2021 the approval rates were with 66.7% lower for (neo)adjuvant indications versus 88.4% in the metastatic and advanced indications. While the approval rates for metastatic and advanced New Active Substances (NAS) applications were similar at SMC as compared to the EMA and the FDA, they were lower for (neo)adjuvant applications at SMC as compared to the EMA and the FDA. The underlying reason in all cases with divergent decisions at SMC as compared to EMA and FDA was that no overall survival (OS) benefit as compared to control arm has been observed in the submitted data package.
Conclusion: Approval and consensus decision rates at SMC in comparison to EMA and FDA were lower for (neo)adjuvant indications but not for advanced and metastastic NAS oncology indications.
期刊介绍：
Although laboratory and clinical cancer research need to be closely linked, observations at the basic level often remain removed from medical applications. This journal works to accelerate the translation of experimental results into the clinic, and back again into the laboratory for further investigation. The fundamental purpose of this effort is to advance clinically-relevant knowledge of cancer, and improve the outcome of prevention, diagnosis and treatment of malignant disease. The journal publishes significant clinical studies from cancer programs around the world, along with important translational laboratory findings, mini-reviews (invited and submitted) and in-depth discussions of evolving and controversial topics in the oncology arena. A unique feature of the journal is a new section which focuses on rapid peer-review and subsequent publication of short reports of phase 1 and phase 2 clinical cancer trials, with a goal of insuring that high-quality clinical cancer research quickly enters the public domain, regardless of the trial’s ultimate conclusions regarding efficacy or toxicity.
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