Cancer And Accelerated Approval: FDA To Crack Down On Single-Arm Trials, Refractory Disease Focus

The US Food and Drug Administration’s Oncology Center of Excellence is kicking off a new project to push sponsors towards more randomized controlled trials and studies of drugs in earlier disease settings as part of accelerated approval applications.

The new emphasis, known as Project Frontrunner, should shorten the period of uncertainty between a drug’s accelerated approval and when a clinical benefit is determined, said FDA’s Oncology Center of Excellence Director Richard Pazdur at the American Society of Clinical Oncology meeting