The FDA today issued new guidance to help drug developers select endpoints for marketing applications with the goal of advancing the efficient development of cancer drugs and biologics.
The guidance — titled Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics — is the first update on this framework in more than a decade and replaces the 2007 guidance.
“As part of FDA’s strategy to continue to encourage the modernization of clinical trials, we’re providing new recommendations for drug developers regarding the most effective clinical trial endpoints to help advance the development of products to treat cancer,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “Over the past several decades, we’ve seen an evolution in cancer care in how treatment effect is measured, and which endpoints are successful measures of disease activity or clinical benefit to patients.
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