Status of oncology drugs with a conditional approval: A cross-sectional comparison of the Food and Drug Administration and Health Canada.

IF 3.1 3区医学 Q2 PHARMACOLOGY & PHARMACY

British journal of clinical pharmacology Pub Date : 2025-06-10 DOI:10.1002/bcp.70135

Joel Lexchin

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Abstract

Aims: This study looks at the status of the same drugs conditionally approved by the Food and Drug Administration and Health Canada for the same oncology indication.

Methods: Lists of oncology drugs with a conditional approval from the Food and Drug Administration and Health Canada were generated and drug pairs with the same indication were matched. Drugs were categorized by status (benefits verified, benefits not yet verified and withdrawn); the median length of time between approval and status was calculated and the 2 regulators were compared.

Results: Eighty-nine drug pairs were analysed. Forty-five (50.6%) drugs had benefits verified by both regulators, 16 (18.0%) had benefits that were not yet verified by both regulators and 6 (6.7%) had been withdrawn by both regulators. The 45 drugs with verified benefits were on the US market for a median of 1120 days before verification compared to a median of 1345 days on the Canadian market (P = .1063, Mann-Whitney test). The 16 drugs with benefits not yet verified had been on the market in the USA for a median of 1373 days vs. a median of 1025 days in Canada (P = .3414, Mann-Whitney test). Out of 67 drugs with concordant status, 14 (20.9%) were on the US market for >1800 days and 27 (40.3%) were on the Canadian market for that length of time (P = .0127, z test).

Conclusions: Reforms to conditional approval systems in both countries need to be made to reduce the time products are on the market without a final status.

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有条件批准的肿瘤药物现状：食品和药物管理局和加拿大卫生部的横断面比较。

目的：本研究着眼于食品和药物管理局和加拿大卫生部有条件地批准用于相同肿瘤适应症的相同药物的状况。方法：生成食品和药物管理局和加拿大卫生部有条件批准的肿瘤药物清单，并匹配具有相同适应症的药物对。药品按状态分类（已验证、未验证和已撤销）；计算批准和状态之间的中位时间长度，并比较两种监管机构。结果：对89对药物进行了分析。45种（50.6%）药物的获益均得到了两个监管机构的验证，16种（18.0%）药物的获益尚未得到两个监管机构的验证，6种（6.7%）药物已被两个监管机构撤销。证实疗效的45种药物在美国市场验证前的中位数为1120天，而加拿大市场验证前的中位数为1345天(P =。1063，曼-惠特尼试验)。16种疗效尚未验证的药物在美国上市的中位数为1373天，而在加拿大上市的中位数为1025天(P =。3414，曼-惠特尼试验)。在67种状态一致的药物中，14种（20.9%）在美国上市的时间为1800天，27种（40.3%）在加拿大上市的时间为1800天（P = 0.05）。0127， z测试)。结论：这两个国家都需要对有条件审批制度进行改革，以减少产品在没有最终地位的情况下上市的时间。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

British journal of clinical pharmacology 医学-药学

CiteScore

6.30

自引率

8.80%

发文量

419

审稿时长

1 months

期刊介绍： Published on behalf of the British Pharmacological Society, the British Journal of Clinical Pharmacology features papers and reports on all aspects of drug action in humans: review articles, mini review articles, original papers, commentaries, editorials and letters. The Journal enjoys a wide readership, bridging the gap between the medical profession, clinical research and the pharmaceutical industry. It also publishes research on new methods, new drugs and new approaches to treatment. The Journal is recognised as one of the leading publications in its field. It is online only, publishes open access research through its OnlineOpen programme and is published monthly.