The FDA is considering changes to the accelerated approval process for oncology.

"In draft guidance, the agency outlined plans to move away from single-arm studies and instead favor randomized controlled trials that can potentially serve as the basis for both accelerated and full approval."

https://www.fiercebiotech.com/biotech/fda-floats-oncology-authorization-shake-pitching-one-trial-model-accelerated-and-full