ARTICLE | Regulation

What accelerated approval has done for cancer

Cancer provides case studies for the good and bad of accelerated approval

August 30, 2021 1:07 PM UTC

Whether dimmer or brighter than it’s ever been before, the future of expedited approval pathways, and especially FDA’s accelerated approval pathway, can heed the lessons offered from the disease area with the richest history of expedited review — cancer.

It’s now axiomatic that cancer has been revolutionized by the introduction of FDA’s accelerated approval pathway. Though the process was introduced in 1992 in response to the HIV/AIDS crisis, its impact has been predominantly in cancer, which represents 63% of the approvals from the pathway’s inception through 2020, and 80% of the accelerated approvals since 2014...