A comprehensive narrative review of real-world evidence (RWE) for 10 recently-approved oncology drugs for breast cancer and other malignancies showed the treatments have led to safer and better outcomes for patients, according to a recent study published in Critical Reviews in Oncology/Hematology.
Published in Critical Reviews in Oncology/Hematology, the review compiled real-world evidence (RWE) for ten innovative oncology drugs approved between 2020 and 2025, examining whether their trial-proven benefits extend to heterogeneous routine-practice populations often underrepresented in randomized controlled trials (RCTs), such as elderly patients, those with comorbidities, or poor performance status.
RWE largely reproduces registrational trial outcomes across breast, lung, urothelial and endometrial cancers, validating these agents’ effectiveness and manageable toxicity in everyday settings. Current evidence from 20 large observational studies shows RWE fills critical gaps in understanding real-world performance, toxicity predictors, treatment patterns and health disparities. Disease causes vary, and current treatments now incorporate these precision agents that have transformed advanced disease management.
“Collectively, findings from RWE underscore that recently approved oncologic therapies retain substantial effectiveness beyond the controlled environment of RCTs,” the authors wrote.
The authors aimed to systematically search, select, and narratively synthesize high-quality real-world evidence from observational studies published from 2020 to 2025 on the effectiveness, safety and generalizability of 10 recently approved oncology drugs for solid tumors: (sacituzumab govitecan, trastuzumab deruxtecan, elacestrant, sotorasib, adagrasib, selpercatinib, capmatinib, tepotinib, enfortumab vedotin, and dostarlimab).
The methods comprised a systematic search of PubMed/MEDLINE, Embase, Scopus, Web of Science, and major conference abstracts from January 2020 to January 2025, with independent dual screening, inclusion restricted to English-language observational cohorts/registries/expanded-access/claims studies enrolling ≥100 patients and reporting efficacy or safety endpoints, followed by structured data extraction, narrative thematic synthesis (no meta-analysis due to heterogeneity), and GRADE certainty appraisal starting from low for observational evidence.
Outcomes identified 20 eligible studies (more than 3400 patients total), demonstrating real-world efficacy and toxicity profiles closely aligned with pivotal RCTs across indications. Improvements could include attempting pooled meta-analysis for homogeneous endpoints, incorporating smaller but complementary studies, standardizing outcome definitions, extending searches to non-English literature, or including direct comparative effectiveness analyses.
“RWE confirms the effectiveness and safety of multiple recently approved oncology drugs reinforcing the external validity of RCTs,” the authors concluded.
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