24 March 2023 - The accelerated approval pathway is commonly used for approval of oncology drugs due to the serious and life-threatening nature of cancer. 

Although single-arm trials have been commonly used to support accelerated approval, a randomised controlled trial is the preferred approach as it provides a more robust efficacy and safety assessment and allows for direct comparisons to an available therapy.

This guidance describes considerations for designing, conducting, and analysing data for trials intended to support accelerated approvals of oncology therapeutics.

Read FDA Guidance