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GUIDANCE DOCUMENT

Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics March 2023

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2023-D-0110
Issued by:
Guidance Issuing Office
Oncology Center of Excellence

The purpose of this guidance is to provide recommendations to sponsors of anti-cancer drugs or biological products on considerations for designing trials intended to support accelerated approval. 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 randomized 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 analyzing data for trials intended to support accelerated approvals of oncology therapeutics.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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All written comments should be identified with this document's docket number: FDA-2023-D-0110.

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