Decoding the EPAR scientific assessment for clinical practice: a tutorial using tislelizumab in NSCLC

European Public Assessment Reports (EPARs) are among the most scientifically rigorous sources available for evaluating newly approved oncology therapeutics, yet their complexity often limits clinical use. This tutorial aims to equip practicing oncologists and clinical pharmacologists with practical strategies for extracting actionable insights from EPARs. Using the regulatory assessment of tislelizumab in non-small cell lung cancer as an exemplar, this tutorial provides a structured framework for navigating EPAR content and translating technical findings into clinical practice. The analysis highlights how the EMA evaluates molecular design, pharmacokinetic modeling, exposure-response relationships, and safety data to guide therapeutic decisions. The tutorial illustrates how population pharmacokinetics informed the adoption of flat dosing, how exposure-efficacy analyses were interpreted in light of confounding by disease severity, and how differential indication approvals were justified by benefit-risk analyses. Mastering EPAR review enables clinicians to refine patient selection, anticipate pharmacologic variability, and better understand the scientific rationale behind a therapeutic label. This framework supports more informed, evidence-based prescribing decisions across oncology practice.