The National Comprehensive Cancer Network (NCCN) expands indications of US Food and Drug Administration (FDA)-approved drugs based on weak evidence, according to a retrospective observational analysis published in the BMJ.

Jeffrey Wagner, a medical student at Oregon Health & Science University, School of Medicine in Portland, and colleagues used 47 new molecular approvals by the FDA between 2011 and 2015 to understand the varying recommendations by the NCCN and FDA on anticancer drugs, as well as evidence that may possibly cause the differences between the contrasting recommendations.

The main outcome was the evaluation of all new and supplemental FDA-approved indications until March 2016 and the compared recommendations made by the NCCN.

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Between 2011 and 2015, the FDA approved 47 drugs for hematologic or solid cancers, which resulted in 69 FDA-approved indications. In contrast, the NCCN recommended the 47 drugs for 113 indications, 39% more than the FDA. The average number of recommendations surpassing FDA approval indications was 0.92, 23% of which were backed by results from randomized controlled trials; 16% were from phase III testing.

The investigators reported that the FDA approved 14% of the excess recommendations after a 21-month follow-up.

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“The NCCN frequently recommends beyond the FDA approved indications even for newer, branded drugs,” the authors stated.

“The strength of the evidence cited by the NCCN supporting such recommendations is weak,” they continued. “Our findings raise concern that the NCCN justifies the coverages of costly, toxic cancer drugs based on weak evidence.”


  1. Wagner J, Marquart J, Ruby J, et al. Frequency and level of evidence used in recommendations by the National Comprehensive Cancer Network guidelines beyond approvals of the US Food and Drug Administration:  Retrospective observational study. BMJ. 2018 March 07. doi: 10.1136/bmj.k668.