A recent workshop summed up the state of play for circulating tumor DNA. Although evidence is building of its utility as a biomarker in many oncology settings, its prognostic value has yet to be proven, limiting any current utility as an endpoint for regulatory use for cancer therapeutics.
Oncology endpoints: The growing pains of an evolving field
FDA approval of a drug or biologic relies on whether there is “substantial evidence” of safety and effectiveness derived from “adequate and well-controlled clinical investigations” according to the Federal Food, Drug, and Cosmetic (FD&C) Act. However, the FDA Modernization Act of 1997 gave FDA the ability to exercise its scientific judgment in deciding exactly what it means to fulfill these requirements. In general, FDA determines the “effectiveness” of a product based on its ability to demonstrate clinical benefit: to prolong life, improve function, and/or improve the way a patient feels.
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