Prescribing Changes After Accelerated vs Regular Approval of Oncology Therapies

In this cross-sectional study, Flatiron Health EHR data from approximately 280 U.S. cancer clinics were analyzed to evaluate oncologists’ prescribing behavior following FDA Accelerated Approval (AA) versus Regular Approval (RA). The results indicate that uptake increased by 23 percentage points after AA, compared to just 1 point after RA, a highly significant difference. Off‑label usage was minimal.

These findings suggest that oncologists broadly embrace therapies granted AA, even when confirmatory evidence is provisional, whereas RA carries minimal marginal influence. This behavior highlights the need for policy reforms that accelerate completion or enforcement of confirmatory trials to ensure early access aligns with robust evidence.

This study leverages real-world oncology data to inform cancer care delivery and approval strategy debates.