FDA is announcing the availability of a revised guidance for industry entitled "Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics." This guidance provides background information and general principles regarding oncology endpoints. The endpoints discussed in this guidance are for drugs to treat patients with an existing cancer. This guidance does not address endpoints for drugs to prevent or decrease the incidence of cancer.

This guidance replaces the final guidance of the same title that published in May 2007. The updates made to this guidance are to clarify information regarding oncology endpoints and to provide updated resources, references, and examples of regulatory approvals. The guidance clarifies how various oncology endpoints can serve different purposes (e.g., clinical endpoint that represents clinical benefit for traditional approval, surrogate endpoint to support traditional approval, surrogate endpoint to support accelerated approval) and provides current thinking on the factors that are considered in making the determination. Other updates include the addition of examples of emerging oncology endpoints and the addition of intermediate clinical endpoints in the discussion of accelerated approval. Throughout the guidance document, the language has been revised for consistency and clarity.

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