Posted by Michael Wonder on 19 Dec 2018
FDA advances new scientific framework to promote greater predictability, efficiency in oncology drug development
19 December 2018 - Today, the U.S. FDA issued guidance, Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics.
The guidance provides recommendations to applicants on endpoints for cancer clinical trials submitted to FDA to support effectiveness claims in applications. This updated guidance will help advance the efficient development of cancer drugs and biologics. Today’s guidance is a revision of the guidance of the same title published in May 2007 and replaces that prior document.
The new updates made to this guidance expand on the information regarding oncology endpoints and 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.
