(HealthDay News) — The National Comprehensive Cancer Network (NCCN) often makes recommendations for new molecular entities beyond the indications approved by the US Food and Drug Administration, according to a study published online in The BMJ.
Jeffrey Wagner, MD, 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% overlapped with FDA-approved indications, and 39% were additional recommendations. An average of 0.92 recommendations were beyond the FDA-approved indications. Overall, 23% of the additional recommendations were based on evidence from randomized controlled trials, and 16% were based on evidence from phase III studies. The FDA granted approval to 14% 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.”
Wagner J, Lammers A, Kaestner V, 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;360 doi:10.1136/bmj.k668