Regulatory and Clinical Outcomes of Nononcology Accelerated Approvals

In an analysis of 50 non-oncology drugs granted FDA accelerated approval from 2013 to 2024, 38% were converted to full approval at a median 3 years later, but over half of these conversions relied on surrogate endpoints rather than direct clinical outcomes. The study raises concerns about the clinical utility of some accelerated approvals and calls for more robust confirmatory trials to ensure patient benefit.