Division of Medical Oncology, Department of Medicine, University of Washington School of Medicine, Seattle, WA, USA.
Cancer Invest. 2021 Feb;39(2):120-123. doi: 10.1080/07357907.2020.1851705. Epub 2021 Jan 7.
Precision oncology has revolutionized the therapeutic landscape of oncology and is a goal for cancer drug development. However, lenient drug approvals by the United States Food and Drug Administration under the auspices of precision oncology are setting up this therapeutic approach to fail. In this commentary, I review two recent FDA drug approvals (pembrolizumab for tumor mutation burden-high solid tumors and olaparib for castration-resistant prostate cancer with deleterious homologous recombination repair mutations) where the FDA indication is broader than the studied population. I explain how these broad approvals stray from principles of precision oncology and can cause harm to patients.
精准肿瘤学改变了肿瘤学的治疗格局，是癌症药物开发的目标。然而，在美国食品和药物管理局的精准肿瘤学的支持下，宽松的药物审批正在使这种治疗方法失败。在这篇评论中，我回顾了最近美国食品和药物管理局批准的两种药物（pembrolizumab 用于肿瘤突变负荷高的实体瘤，olaparib 用于有有害同源重组修复突变的去势抵抗性前列腺癌），其中美国食品和药物管理局的适应证比研究人群更广泛。我解释了这些广泛的批准如何偏离精准肿瘤学的原则，并可能对患者造成伤害。
