NCCN Recommends New Drugs Beyond FDA-Approved Indications
FRIDAY, March 9, 2018 -- The National Comprehensive Cancer Network (NCCN) often makes recommendations for new molecular entities beyond the indications approved by the U.S. Food and Drug Administration, according to a study published online March 7 in The BMJ.
Jeffrey Wagner, M.D., from the Oregon Health & Science University in Portland, and colleagues conducted a retrospective observational study involving 47 new molecular entities approved by the FDA between 2011 and 2015 for adult hematologic or solid cancers. These approved indications were compared with all NCCN recommendations as of March 25, 2016.
The researchers found that the 47 drugs were authorized for 69 FDA-approved indications. The NCCN, however, recommended these drugs for 113 indications, of which 62 percent overlapped with FDA-approved indications, and 39 percent were additional recommendations. An average of 0.92 recommendations were beyond the FDA-approved indications. Overall, 23 percent of the additional recommendations were based on evidence from randomized controlled trials, and 16 percent were based on evidence from phase III studies. The FDA granted approval to 14 percent of the additional recommendations during 21 months of follow-up.
"The NCCN frequently recommends beyond the FDA-approved indications even for newer, branded drugs. The strength of the evidence cited by the NCCN supporting such recommendations is weak," the authors write. "Our findings raise concern that the NCCN justifies the coverage of costly, toxic cancer drugs based on weak evidence."
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Posted: March 2018