Association of different approvals with Chinese Society of Clinical Oncology recommendation levels for solid tumor drugs: a cross-sectional analysis.

Abstract

In China, many solid tumor drugs have been approved via the accelerated approval (AA) pathway. We extracted data regarding indications for solid tumor-treating drugs approved by the National Medical Products Administration (NMPA) between 2015 and 2023, along with their corresponding Chinese Society of Clinical Oncology (CSCO) guideline recommendation levels and inclusion data. Descriptive statistics, Fisher's exact tests, and t-tests were used to examine associations between NMPA approval pathways and CSCO guideline recommendation levels. The study included 92 solid tumor drugs comprising 191 indications. Sixty-three indications were approved via the regular approval (RA), and 128 were approved via the AA. One hundred fifty-seven indications obtained CSCO guideline recommendation level I, 28 obtained level II, and 6 obtained level III. No significant difference in the recommendation level was observed between the approval pathways. The average time for the indications approved via the RA to obtain the recommendation level was 2.03 months before NMPA approval. The average time for the indications approved via the AA to obtain the level was 6.66 months after NMPA approval. Compared with initial levels, 57 indications had their recommendation levels upgraded. Most indications obtain the CSCO guideline recommendation level I, with similar likelihoods across obtaining different approval pathways. Indications approved via the RA tended to obtain the CSCO guideline recommendation earlier than those via the AA. Given the limitations in data completeness and CSCO guideline coverage, these findings should be interpreted with caution. Clearer criteria for evaluating recommendation levels and standardizing rating procedures will enable CSCO guidelines to better support clinicians and patients.