癌症药物批准的延迟一直是中国政策制定者的主要担忧。已实施政策,以加快新的癌症药物和适应症的推出。这项研究旨在评估中国和美国在批准方面的异同。定时,以及2001年至2020年间癌症药物适应症的临床获益证据。
■这项研究回顾性地确定了从1月1日起在中国和美国批准的所有癌症药物和适应症,2001年至2020年12月31日,并描述了批准时间以及提交和审查时间的差异。收集了截至2020年12月31日的总体生存获益证据的信息。使用单变量和多元逻辑回归分析来评估获益证据和其他因素是否影响中国癌症药物适应症批准的倾向和时机。
■在2001年至2020年之间,确定了与美国批准的145种癌症药物相对应的229种适应症。其中,到2020年底,中国还批准了80种适应症(34.9%)。在美国批准后的中位数为1273.5天,中国批准了癌症药物适应症。中国癌症药物适应症的中位提交和审查时间差分别为1198.0天和180.0天。提交时间差异占批准时间差异的大部分(p<0.001)。总体生存获益证据支持的适应症的中位审查时间差异(145.0天)比没有此类证据的适应症(235.0天,p=0.008)。有总体生存获益证据的适应症在中国获得批准的可能性比没有此类证据的适应症高3.94倍(p=0.001)。控制批准年度,癌症类型,以及癌症的发病率。
■FDA批准的表明生存获益的癌症药物适应症在中国更有可能获得批准,与没有此类证据的适应症相比,监管审查时间更短。鉴于制造商提交时间是中国癌症药物批准时间的主要驱动因素,应探讨影响提交时间的因素。
■没有资金。
UNASSIGNED: Perceived delays in cancer drug approvals have been a major concern for policymakers in
China. Policies have been implemented to accelerate the launch of new cancer drugs and indications. This study aimed to assess similarities and differences between
China and the United States in the approvals, timing, and clinical benefit evidence of cancer drug indications between 2001 and 2020.
UNASSIGNED: This study retrospectively identified all cancer drugs and indications approved in both China and the United States from January 1st, 2001 to December 31, 2020, and described differences in approval times as well as in submission and review times. Information on the availability of overall survival benefit evidence by December 31, 2020, was collected. Univariate and multiple logistic regression analyses were used to assess whether evidence of benefit and other factors affected the propensity and timing of approvals of cancer drug indications in China.
UNASSIGNED: Between 2001 and 2020, 229 indications corresponding to 145 cancer drugs approved in the United States were identified. Of those, 80 indications (34.9%) were also approved in
China by the end of 2020. Cancer drug indications were approved in
China at a median of 1273.5 days after approval in the United States. The median submission and review time differences for cancer drug indications in China were 1198.0 days and 180.0 days respectively. Submission time differences accounted for most of the approval time differences (p < 0.001). Indications supported by overall survival benefit evidence had shorter median review time differences (145.0 days) than those without such evidence (235.0 days, p = 0.008). Indications with overall survival benefit evidence were 3.94 times more likely to be approved in China compared to those without such evidence (p = 0.001), controlling for approval year, cancer type, and the prevalence of cancer by site.
UNASSIGNED: FDA-approved cancer drug indications demonstrating a survival benefit were more likely to receive approvals in China with shorter regulatory review times compared to indications without such evidence. Given that manufacturer submission times were the main driver of cancer drug approval times in
China, factors influencing submission timing should be explored.
UNASSIGNED: No funding.