Observational studyCancer medicine2025
Cancer Drugs Approved Based on Surrogate Endpoint: A Retrospective Observational Study in the United States and China.
Observational study in Cancer medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Epidemiological Characteristics, Target Distribution, and Clinical Value of Targeted Anticancer Drugs Approved in China: A Cross-Sectional Study.Clinical pharmacology and therapeutics · 2026Article
- Clinical value and cost-effectiveness analysis of conditionally approved anticancer drugs in China from 2015 to 2023.Translational cancer research · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
Abstract
backgroundHundreds of cancer drugs are approved globally based on surrogate endpoint response rate (RR). However, the characteristics of RR-based approvals remain unknown.
methodsIn this retrospective study, all cancer drug-indication pairs approved based on RR in the United States and China up to December 2023 were analyzed.
resultsA total of 249 RR-supported drug-indication pairs were identified in the United States and 98 in China. In the United States, 98 of the 249 (39.4%) indications were granted regular approval (RA), whereas in China, only 21 of 98 (21.4%) approvals followed this regulatory pathway, with the remainder receiving accelerated approval (AA). The conversion rate from AA to RA was significantly lower in China compared to the United States (13.3% vs. 28.1%, p < 0.001). The proportion of AA withdrawals was significantly lower in China compared to the United States (1.0% vs. 10.4%, p < 0.001). Among all indications, the median RR in China was 60.9% (IQR, 35.8%-75.0%), which was significantly higher than the 45.0% (IQR, 29.0%-61.0%) in the United States (p < 0.001). In China, 18 of the 98 (18.4%) had an RR less than 30%. In contrast, in the United States, 26.9% of the 249 had an RR less than 30%.
conclusionsCompared to the United States, RR-supported approvals in China are characterized by higher RR values and a stricter RA pathway. Regulatory authorities in both countries may need to consider both the quantity and quality during cancer drug development based on surrogate endpoints.
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