How many years has the FDA’s Accelerated Approval Program added for patients? New research quantifies the benefit.
The FDA’s Accelerated Approval Program (AAP) has faced scrutiny, but the program’s true impact on patient survival has remained largely unquantified—until now. A new study estimates that oncology drugs approved through the AAP between 2006 and 2022 contributed to approximately 263,000 additional life years for cancer patients in the U.S.
Researchers analyzed data from 69 cancer treatments approved under the program where survival data was available, using clinical trial results, FDA approval records and real-world drug uptake data. The findings reveal that the AAP has provided significant survival benefits to nearly one million patients with high unmet medical needs.
These results underscore the critical role of the AAP in expediting access to life-saving therapies. As policy discussions around the program continue, its demonstrated impact on patient survival must remain a key consideration.
This research was funded by Johnson & Johnson Innovative Medicine and conducted in collaboration with researchers at Evidera, led by Dr. Ágnes Benedict. For full details on the study design, methods and limitations, see: Benedict Á, et al. Life years gained from the FDA Accelerated Approval program in oncology: a portfolio model. J Natl Compr Cancer Netw. 2024; 22(6): 382-389. doi: 10.6004/jnccn.2024.7010
Further reading:
- J&J IM Head of Global Regulatory Policy and Intelligence Ginny Beakes-Read: “Cancer patients need more time. Accelerated approval helps give them that.”