Researchers published in JAMA raised concerns about how the US FDA is using accelerated approval in oncology, arguing that the pathway is being underutilized even as evidence standards appear to shift. In a cross-sectional analysis of 385 adult cancer drug approvals from 2006–2025, authors found rising reliance on response rate and single-arm trial designs, alongside a decline in approvals tied to overall survival and progression-free survival. The paper highlights a key tension: offering up-front regular approval based on surrogate measures can reduce the “safety net” of confirmatory trials that accelerated approval is designed to require. The authors also noted a broader pattern of weaker-evidence regular approvals compared with earlier years. Among the study’s headline figures, 154 of 385 total approvals (40%) were novel adult cancer drugs and 231 (60%) were new supplemental indications; more than a quarter used an accelerated approval pathway, with the remainder for advanced cancer indication expansions.