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.

ABSTRACT:

Objective

To determine the differences between recommendations by the National Comprehensive Cancer Network (NCNN) guidelines and Food and Drug Administration approvals of anticancer drugs, and the evidence cited by the NCCN to justify recommendations where differences exist.

Design

Retrospective observational study.

Setting

National Comprehensive Cancer Network and FDA.

Participants

47 new molecular entities approved by the FDA between 2011 and 2015.

Main outcome measures

Comparison of all FDA approved indications (new and supplemental) with all NCCN recommendations as of 25 March 2016. When the NCCN made recommendations beyond the FDA's approvals, the recommendation was classified and the cited evidence noted.

Results

47 drugs initially approved

SUBMITTER: Wagner J 

PROVIDER: S-EPMC5838851 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature