The FDA’s Accelerated Approval Program (AAP) helps patients with serious health conditions access life-saving medications more quickly. Over the past 30 years, this program has allowed more than 280 drugs to be approved based on early evidence, like tumor shrinkage or progression-free survival, instead of waiting for complete survival results.
Retrospective research shows that from 2006 to 2022, over 911,000 cancer patients gained about 263,000 extra life years thanks to earlier access to treatments approved through the AAP. While some critics worry that the program may approve ineffective drugs, ongoing evaluations of new therapies are robust and the process of withdrawals has been strengthened recently. Many patients and healthcare professionals support it for providing timely access to new therapies.
Overall, the AAP has played a vital role in saving lives and improving care for patients with urgent medical needs, and future discussions should focus on its positive impact on patients.
Read the perspective in the Journal of Clinical Pathways.
This research was funded by Johnson & Johnson Innovative Medicine. For full details on the study design, methods and limitations, see: Doherty B, et al. Every second counts: the impact of FDA’s Accelerated Approval Program. J Clin Pathw. 2025; 11(2). Available from: https://www.hmpgloballearningnetwork.com/site/jcp/blog/every-second-counts-impact-fdas-accelerated-approval-program