Nearly two years ago, the Food and Drug Administration published a table of surrogate endpoints that drug developers could reference as they chart a course for winning regulatory approval. But a new study suggested there is a problem — the table fails to provide sufficient evidence that the endpoints listed actually offer improved overall survival in breast cancer patients.
Due to “weak or missing correlations” with overall survival, the researchers argued that in most cases, treatments for breast cancer should be granted so-called accelerated approval, a move reserved for medicines that can serve unmet needs. Why? Accelerated approvals require drug makers to conduct followup studies to confirm clinical benefits.