The US FDA Accelerated Approval of sotorasib required the sponsor to conduct a randomized trial that compared the safety and efficacy of the approved dose with a lower dose. These results, recently disclosed, have important implications for patients, payers, oncologists and the pharmaceutical industry.

中文翻译：

---

Sotorasib 剂量和增量成本无效——对利益相关者的影响和教训

美国 FDA 加速批准 sotorasib 要求申办者进行一项随机试验，比较已批准剂量与较低剂量的安全性和有效性。最近披露的这些结果对患者、付款人、肿瘤学家和制药行业具有重要意义。