ArticleFrontiers in pharmacology2026
Comparison of the conditional approvals for anticancer drugs supported by single-arm trials in China and the United States: clinical evidence, post-marketing requirements, and regulatory outcomes.
Article in Frontiers in pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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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.
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Who cites it
1 citing paper in PubMed.
- Regulatory Convergence in Cell and Gene Therapy: Harmonizing Quality, CMC, and Approval Pathways Across the FDA, EMA, PMDA, and Emerging Markets.Biotech (Basel (Switzerland)) · 2026Review
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Purpose: Describe and compare the clinical evidence, post-marketing requirements, and regulatory outcomes of all anticancer drugs that have obtained conditional or accelerated approval based on single-arm trial data in China and the United States. Methods: This paper took all the anticancer drugs that had received accelerated or conditional approval based on single-arm trials in the United States and China as of August 31, 2025, as a research sample, and conducted a comparative analysis of the approval status based on single-arm trials in the United States and China from three aspects: the clinical evidence for the accelerated or conditional approval, the conditions attached to the marketing, and the regulatory outcomes. Results: Regarding clinical evidence, the phase and number of pivotal clinical trials and sample size in China and the United States were similar, with significant differences in geographic distribution and supporting evidence. In terms of the conditions attached to marketing, there were significant differences between the United States and China in the purpose and confirmatory trial design requirements. In terms of regulatory outcomes, significant differences existed in the time taken to convert to regular approval (RA) and the response rate (RR) of anticancer drugs converted to regular approval in China and the United States. Among these drugs, those simultaneously granted accelerated or conditional approval in both countries based on single-arm trials experienced a significant approval lag in China. Only two conditional approvals were withdrawn in China. At the same time, there was a statistically significant difference between the RR values of anticancer drugs withdrawn in the United States due to unproven clinical benefits and those withdrawn for other reasons. Conclusion: There are substantial differences between the United States and China across multiple aspects. Compared with the experience of the United States for more than 30 years, China is still in the initial stage, and it is advisable for China to thoroughly learn from the experiences and lessons of the United States to optimize its conditional approval pathway for anticancer drugs supported by single-arm trials.
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