In 2016, the then US President Barack Obama announced the Cancer Moonshot with a view to making 10 years’ worth of progress in cancer prevention, diagnosis and treatment in only 5 years. This Perspective evaluates the FDA approvals of therapeutic agents for use in solid tumour oncology for the period 2017–2021 against the aspirations of the Cancer Moonshot. In the past 5 years, the FDA issued an unprecedented 161 new approvals of therapeutic agents for various indications in adult patients with solid tumours. However, less than a third (27%) of the newly approved medicines are supported by unequivocal evidence of an overall survival benefit; most are supported by positive signals from surrogate end points. Herein, the European Society for Medical Oncology Magnitude of Clinical Benefit Scale version 1.1 was used to evaluate the clinical value of the therapies granted FDA approval during the period 2017–2021. The results of this appraisal indicate a low level of clinical benefit for a substantial proportion (~20%) of the new indications, with most (~44%) providing intermediate benefit. The data suggest that, beyond increases in the sheer quantity of approvals, considerable improvement in the quality of the approved treatments is required to more confidently ensure that the clinical benefits are real and substantial enough to clearly justify the risks to patients.

2016年，时任美国总统奥巴马宣布了癌症登月计划，旨在仅用5年时间，在癌症预防、诊断和治疗方面取得10年的进步。本展望评估 FDA 批准的用于实体肿瘤肿瘤学的治疗剂在 2017-2021 年期间针对癌症登月计划的愿望。在过去的 5 年中，FDA 发布了前所未有的 161 项针对成人实体瘤患者各种适应症的治疗药物的新批准。然而，只有不到三分之一（27%）的新批准药物有明确的总体生存获益证据支持；大多数都得到来自替代终点的积极信号的支持。在此，欧洲医学肿瘤学会临床获益量表第 1 版。1 用于评估在 2017-2021 年期间获得 FDA 批准的疗法的临床价值。该评估结果表明，大部分（~20%）新适应症的临床获益水平较低，大多数（~44%）提供中等获益。数据表明，除了批准数量的增加外，还需要大幅提高批准治疗的质量，以更有信心地确保临床益处是真实的和实质性的，足以清楚地证明对患者的风险是合理的。