Overall Survival Benefits of Cancer Drugs Approved in China From 2005 to 2020
- The study evaluates the overall survival (OS) benefit of cancer drugs approved in China between 2005 and 2020.
- Out of 141 cancer drug indications approved, 68 showed a documented overall survival benefit, while 34 did not prolong life.
- Recent regulatory reforms in China aim to improve the availability of new cancer drugs, but the clinical benefits of these therapies need ongoing assessment.
- The study analyzed publicly available data and regulatory documents from the National Medical Products Administration and reviewed literature published up to June 2021.
- Less than one-third of cancer drug indications approved only in China had evidence of OS benefits, compared to more than half of those also approved in the US or Europe.
- The findings suggest a need for regular monitoring of the clinical benefits of new cancer therapies in China, especially as approvals increasingly rely on single-arm trials or immature survival data.
The primary goal of cancer drug therapy is to prolong life or improve quality of life. Overall survival (OS) is the most reliable clinical trial endpoint to inform regulatory approvals of new cancer drugs. However, most cancer drugs approved in the US and Europe lack evidence of OS benefit. For instance, more than two-thirds of cancer drug approvals granted by the US Food and Drug Administration (FDA) between 2008 and 2012 were based on surrogate endpoints, and only 14% of drugs initially approved on the basis of surrogate endpoints had demonstrated OS benefits after a median follow-up of 4.4 years. Further, drugs met the threshold for clinically meaningful benefit in less than half of trials supporting solid tumor indication approvals by the FDA between 2006 and 2016. Similarly, among cancer drugs approved by the European Medicines Agency (EMA) between 2009 and 2013, only 51% showed significant improvement in survival or quality of life at a minimum of 3.3 years follow-up, and survival gains over existing therapy were marginal.
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