Cancer nanomedicine has evolved from the 1995 landmark approval of Doxil® into a programmable platform of precision oncology. The field now progresses along a coherent continuum that begins with passive enhanced permeability and retention (EPR)-mediated tumor accumulation, advances to active ligand-receptor targeting, and culminates in stimuli-responsive carriers whose cargo is liberated only when triggered by endogenous (acidic pH, redox imbalance, elevated GSH, dysregulated enzymes, ROS) or exogenous (light, magnetic, ultrasound, X-ray, electric) cues intrinsic to the tumor microenvironment (TME). This review maps this continuum, highlighting how the integration of patient-specific multi-omics data with artificial intelligence (AI) is converting tumor heterogeneity into quantitative design rules for nanocarrier optimization, validated in patient-derived organoids. Despite over 15 FDA-approved cancer nanomedicines and a robust clinical pipeline, translation is impeded by biological barriers, protein corona-mediated toxicity, manufacturing scalability issues, and a fragmented regulatory landscape. To bridge this bench-to-bedside chasm, we propose a convergent roadmap: safe-by-design engineering, quality-by-design modular manufacturing, and AI-guided digital twins coupled with micro/nano-robotic delivery for real-time, adaptive dosing. Realizing this vision will transform nanomedicine from an empirical carrier technology into a patient-calibrated, closed-loop therapeutic engine, cementing its role as the frontline of precision oncology.

Department of Inorganic Chemistry University of Chemistry and Technology Prague Technická 5 Prague 616628 Czech Republic

Department of Pharmacology Institute of Pharmacy Faculty of Pharmaceutical and Allied Health Sciences Lahore College for Women University Lahore Pakistan

Institute of Chemical Sciences Bahauddin Zakariya University Multan 60800 Pakistan

Key Laboratory of Joint Diagnosis and Treatment of Chronic Liver Disease and Liver Cancer of Lishui Central Laboratory of The Lishui Hospital of Wenzhou Medical University The 1st Afffliated Hospital of Lishui University Lishui People's Hospital Lishui Zhejiang 323000 China

Oujiang Laboratory School of Pharmaceutical Sciences Wenzhou Medical University Wenzhou Zhejiang 325000 China

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