Cancer Discov. 2023 Oct 5;13(10):OF3. doi: 10.1158/2159-8290.CD-NB2023-0058.
The FDA is ramping up Project FrontRunner, which urges drugmakers to seek accelerated approval of experimental drugs as first-line treatments for patients with advanced or metastatic disease, rather than focusing on patients who have tried multiple therapies and/or exhausted available options. Experts say the program has the potential to expand access while improving the risk-benefit assessment of new drugs by initiating randomized controlled trials earlier in the drug development process.
FDA 正在加紧推进 FrontRunner 项目，该项目敦促制药商寻求加速批准实验性药物，将其作为晚期或转移性疾病患者的一线治疗药物，而不是专注于那些已经尝试过多种疗法和/或用尽现有治疗方案的患者。专家表示，该项目有可能在新药的风险-收益评估方面取得进展，通过在药物开发过程的早期启动随机对照试验来扩大药物的可及性。
