One of the leading entities that issues physician guidelines for cancer medicines frequently recommends off-label uses beyond those endorsed by regulators, and relies on “weak evidence” to make its influential decisions, according to a new analysis published in BMJ.
Of 47 cancer drugs approved by the Food and Drug Administration between 2011 and 2015, the National Comprehensive Cancer Network recommended 113 uses for the medicines, while the agency endorsed the treatments for 69 uses. Of the 44 additional NCCN recommendations, 14, or 32 percent, permitted use for treating a cancer other than what was specified by the FDA.
Moreover, 10 NCCN recommendations, or 23 percent, were based on evidence from randomized controlled trials, while seven, or 16 percent, were based on evidence from Phase 3 studies. By contrast, among 83 consecutive cancer drugs approved by the FDA over a similar period, 58 percent were based on evidence from randomized controlled trials, which are considered the gold standard for assessing safety and effectiveness. And a subsequent follow-up found that just six of the additional recommendations had received FDA approval.
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