Researchers writing in JAMA raised alarms about what they describe as underutilization of the FDA’s accelerated approval pathway in adult oncology. A cross-sectional analysis of 385 adult cancer drug approvals from 2006–2025 found a decline in approvals based on overall survival and progression-free survival alongside a shift toward response-rate endpoints and weaker evidentiary bases. The authors, led by Brian Shkabari and colleagues at the Sinclair Cancer Research Institute, said the pattern is problematic because it can remove the “safety net” of confirmatory trials designed to verify clinical benefit and safety when accelerated approval is granted. The paper also reported increasing use of regular approvals and expansion of indications based on surrogate endpoints. Across the period, FDA approved 154 novel adult cancer drugs and 231 supplemental new indications, with over a quarter of the total approvals conducted via accelerated approval. The study excluded nononcologic approvals and certain categories such as diagnostics, hematologics, and dosage changes, focusing the analysis on adult cancer medicines. For development teams, the paper adds to scrutiny around how evidence hierarchies are applied in modern oncology regulation—particularly when surrogate responses increasingly drive label decisions.
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