In 2023, the US FDA approved several new cancer drugs and biologic agents, including seven small-molecule inhibitors, four bispecific T cell engagers, two anti-PD-1 antibodies and one cell therapy product. Regulatory focus areas included analyses of biomarker-positive subgroups that drive efficacy, equipoise in randomized controlled trials and a new authority to require confirmatory trials be underway before accelerated approval.

中文翻译：

---

FDA 于 2023 年批准：生物标志物阳性子集、平衡和效益验证

2023年，美国FDA批准了多种新型抗癌药物和生物制剂，包括七种小分子抑制剂、四种双特异性T细胞接合剂、两种抗PD-1抗体和一种细胞治疗产品。监管重点领域包括对生物标志物阳性亚组进行分析，这些亚组可提高疗效、随机对照试验中的平衡，以及要求在加速批准之前进行验证性试验的新授权。