Biomarkers Supporting Drug Approvals Lack Strong Supporting Data, Study Says

Almost 60 percent of surrogate markers supporting FDA approvals for nononcologic drugs for chronic diseases aren’t backed up by meta-analyses showing a strong association between the marker and relevant clinical endpoints, a new JAMA Network study says.

The FDA’s Adult Surrogate Endpoint Table contains 37 markers that may be used as primary end points for clinical trials of drugs for 32 chronic, nononcologic diseases. But according to Joshua D. Wallach of Emory University, Atlanta and colleagues, 22 of those markers (59 percent) weren’t backed up by meta-analytic data, which the FDA has said is the minimum evidence level necessary for approval.

Additionally, the investigators found that the FDA has OK’d nearly 80 percent of these non-supported surrogate markers as appropriate endpoints for a traditional approval. Of these, only three were supported by consistent, high-quality meta-analytic data demonstrating a high association between marker and clinical outcome.

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