USA – FDA Revises Guidance on Oncology Endpoints

Replacing a guidance from 2007, this latest guidance from the US Food and Drug Administration (FDA) clarifies how certain oncology endpoints can serve different purposes based on the context of use, and it provides the agency’s current thinking on factors considered in making these determinations on which endpoints are used in what context.

The new updates made to this guidance also expand on the information with respect to oncology endpoints and provide updated resources, references and examples of regulatory approvals.

Other updates include the addition of examples of emerging oncology endpoints and the addition of intermediate clinical endpoints in the discussion of accelerated approval.

“We continue to encourage companies to engage with FDA early in the drug development process so that we can work with them to apply modern and efficient trial designs, as well as explore novel endpoints, such as minimal residual disease, which recently formed the basis of approval for a new treatment for a type of leukemia,” FDA Commissioner Scott Gottlieb said…