Evolent Health January 23, 2025
A recent study offers insights to an under-examined question at the heart of the FDA’s accelerated approval process.
Earlier this year, I wrote in Evidence-Based Oncology about the challenges surrounding drugs using the FDA’s accelerated approval pathway. These therapies first enter the market based on promising early results in clinical trials, yet we often wait years to find out whether they deliver on that promise for the most meaningful endpoints, such as extending survival.
Sometimes, they are true breakthroughs, and the fast-track process saves many additional lives. But often, that is not the case. According to research presented at the American Association for Cancer Research 2024 annual meeting and subsequently published in JAMA, among 46 oncology indications with...