FDA first to global follow-on: alignment in expedited oncology approvals across EMA, TGA, and PMDA

Abstract

Introduction – Oncology drugs often receive their first expedited approval in the United States, yet the degree of alignment with subsequent regulatory decisions in other jurisdictions remains uncertain. We examined concordance in evidentiary evaluation and review timelines between the US Food and Drug Administration (FDA)-first expedited oncology approvals and subsequent decisions by the European Medicines Agency (EMA), Therapeutic Goods Administration (TGA), and Pharmaceuticals and Medical Devices Agency (PMDA). Methods – This study included all oncology drugs that received their first expedited approval from the FDA in 2019–2023. Subsequent EMA, TGA, and PMDA decisions were evaluated in pairwise comparison with the FDA. Concordance with the FDA was assessed for expedited pathway use, pivotal trial selection, and three analytical components (primary endpoint, target population, and data cut-off date (DCO)). Submission interval and review duration relative to the FDA were compared using Wilcoxon rank-sum tests. Results – Among 36 FDA expedited oncology approvals, EMA (n = 28), TGA (n = 18), and PMDA (n = 15) granted subsequent authorizations through expedited or standard pathways. TGA showed the highest concordance with the FDA, retaining expedited pathways in 72% of cases and closely mirroring the FDA's analytical interpretations in the same pivotal trials. EMA maintained a similar rate of expedited use (71%) but often broadened target populations or used later DCOs (median +136 days). PMDA, in contrast, relied mainly on standard approvals (93%) with Japan-specific population analyses. Across all agencies, primary endpoint choice remained concordant with the FDA. EMA had the shortest submission lag (median 27 days), whereas TGA cases exceeded 600 days. All agencies had longer review duration than the FDA. Discussion – These findings highlight the need for international harmonization of regulatory frameworks and evidentiary thresholds to promote consistency in approval decisions and accelerate global access to innovative cancer therapies. © 2026 Kim, Urushihara, Choi and Bae.