Genentech, Inc., South San Francisco, CA 94080, USA.
Department of Pharmacy, University of Washington, Seattle, WA 98195, USA.
Future Oncol. 2024;20(16):1099-1110. doi: 10.2217/fon-2023-0514. Epub 2024 Jan 23.
We investigated the effect of shortening time between innovations with the accelerated approval (AA) pathway on patient outcomes for three solid tumors. This real-world analysis evaluated patients receiving sequential AA pathway-approved innovations after initial treatment with existing therapies in three solid tumor case studies. Outcomes attributable to AA were estimated and assumed approval occurred at the time of conversion to approval and extrapolated to the US population. Survival gains from accessing innovative therapies were 2.3-3.8-times higher when using the AA pathway. At the US population level, AA was associated with ∼8000 life-years gained across all three tumor case studies. In areas of rapid clinical development, the value of existing therapies can be enhanced by earlier access to AA pathway innovations and should be considered when evaluating the AA program.
我们研究了通过加速审批（AA）途径缩短创新之间时间间隔对三种实体瘤患者结局的影响。这项真实世界分析评估了在初始治疗后接受现有疗法治疗的患者在三种实体瘤病例研究中接受序贯 AA 途径批准创新的情况。对归因于 AA 的结果进行了估计，并假设在转换为批准时获得批准，并外推至美国人群。使用 AA 途径可使获得创新疗法的生存获益提高 2.3-3.8 倍。在所有三个肿瘤病例研究中，AA 与美国人群中约 8000 个生命年的获益有关。在快速临床开发领域，通过更早地获得 AA 途径的创新，可以提高现有疗法的价值，在评估 AA 项目时应予以考虑。
