Most novel cancer drug approvals based on limited evidence. MedTwitter CancerResearch
Over the past 2 decades, novel cancer drugs have increasingly received priority review by the US Food and Drug Administration , but these drugs are often approved on the basis of a single clinical trial in which surrogate endpoints were measured and in which there was no control group, a new analysis found.
To assess the quality of evidence, the study authors analyzed all pivotal clinical trials and nonpivotal randomized controlled trials for cancer drugs the FDA approved for the first time between 2000 and 2020. Most indications were supported by only a single clinical trial, and nearly half of the indications were approved without supporting evidence from an RCT. Only 11 indications were approved with evidence from two RCTs. The clinical trials that led to approval were typically small, with fewer than 250 patients.
While the approved novel cancer drugs showed strong effect sizes for surrogate endpoints, such as progression-free survival and tumor response , the effect on overall survival was more modest. Novel drugs improved overall survival relatively by 25% , with an absolute median overall survival increase of 2.55 months.
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