Understanding the growing gap between approval and access
Expedited regulatory pathways have enabled faster approvals in oncology, often based on early efficacy signals in high-need populations. Yet the same evidence that supports approval frequently falls short of payer and HTA expectations for durability, comparative effectiveness, and value. This paper examines how evidentiary thresholds diverge between regulators and payers, why this gap is widening across novel oncology modalities, and what it means for sponsors seeking to translate early approval into sustained access.