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<p>The rapid evolution of oncology therapeutics, particularly targeted agents, antibody–drug conjugates, and immunotherapies has outpaced existing regulatory frameworks for detecting and managing cardiotoxicity. Current gaps include inconsistent cardiac safety requirements across development phases, limited incorporation of Cardio-Oncology endpoints within expedited approval pathways, and inadequate harmonization of post-marketing signal detection. These deficiencies underscore the need for a modernized, system-level approach that integrates regulatory science with real-world cardiovascular risk. This review examines approval processes of the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA), including expedited pathways such as Breakthrough Therapy, Accelerated Approval, PRIority Medicines (PRIME), and upstream activities in pivotal trials. It highlights their strengths in pre-approval drug dose safety and reducing time-to-therapy while critically evaluating limitations in pre-approval cardiac phenotyping, reliance on surrogate endpoints for cardiotoxicity assessment, and constrained post-market surveillance infrastructures that delay informed, patient-centered understanding of safety and efficacy following drug approval.</p>

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Regulatory challenges and current policy for cardiotoxicity detection in oncology drug development

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月29日

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  • Richard C. Becker

摘要

The rapid evolution of oncology therapeutics, particularly targeted agents, antibody–drug conjugates, and immunotherapies has outpaced existing regulatory frameworks for detecting and managing cardiotoxicity. Current gaps include inconsistent cardiac safety requirements across development phases, limited incorporation of Cardio-Oncology endpoints within expedited approval pathways, and inadequate harmonization of post-marketing signal detection. These deficiencies underscore the need for a modernized, system-level approach that integrates regulatory science with real-world cardiovascular risk. This review examines approval processes of the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA), including expedited pathways such as Breakthrough Therapy, Accelerated Approval, PRIority Medicines (PRIME), and upstream activities in pivotal trials. It highlights their strengths in pre-approval drug dose safety and reducing time-to-therapy while critically evaluating limitations in pre-approval cardiac phenotyping, reliance on surrogate endpoints for cardiotoxicity assessment, and constrained post-market surveillance infrastructures that delay informed, patient-centered understanding of safety and efficacy following drug approval.