Real-world evidence for 10 oncology drugs approved in the last 5 years: A comprehensive narrative synthesis.

[IMPORTANCE] Randomized controlled trials (RCTs) establish the efficacy of new oncology drugs but often exclude older adults, patients with comorbidities, and individuals with poorer performance status. Real-world evidence (RWE) is therefore essential to determine whether trial benefits translate to the broader populations treated in routine practice.

[OBJECTIVE] To synthesize contemporary RWE on the effectiveness and safety of ten oncology drugs approved between 2020 and 2025 for solid tumors, focusing on studies with ≥ 100 patients to maximize robustness and generalizability.

[EVIDENCE REVIEW] A systematic search of PubMed/MEDLINE, Embase, Scopus, Web of Science, and major conference proceedings (ASCO, ESMO, AACR) identified observational cohorts, registries, expanded-access programs, and claims-based studies published from January 2020 to January 2025.

[FINDINGS] Twenty studies (N > 3400) met inclusion criteria: breast cancer (9), lung cancer (7), urothelial carcinoma (3), and endometrial cancer (1). In breast cancer, sacituzumab govitecan reproduced ASCENT outcomes (ORR 27-30 %; PFS 4.8-5.2 months), trastuzumab deruxtecan achieved ORRs near 70 % in HER2-positive disease and median PFS 7.5 months in HER2-low cohorts, and elacestrant showed real-world time-to-next-treatment of 7.9-10.8 months in ESR1-mutant ER+ /HER2 - disease. In NSCLC, sotorasib and adagrasib demonstrated ORRs of ∼28-34 % and PFS 3.5-6 months, selpercatinib provided durable disease control, and MET inhibitors (capmatinib, tepotinib) yielded PFS around 6-7 months. In urothelial carcinoma, enfortumab vedotin produced ORRs of 31-73 % across datasets. In endometrial cancer, dostarlimab generated highly durable responses in dMMR/MSI-H disease.

[CONCLUSIONS] RWE confirms the effectiveness and safety of multiple recently approved oncology drugs reinforcing the external validity of RCTs.