Speed and nature of national comprehensive cancer network updates following food and drug administration approvals & withdrawals

To characterize the speed and nature of National Comprehensive Cancer Network (NCCN) guideline updates following Food and Drug Administration (FDA) approvals and withdrawals. We conducted a retrospective observational study to measure and compare the speed of updates to the NCCN guidelines following FDA cancer approvals and withdrawals between October 2022 and July 2024. We also descriptively analyzed the frequency of specific modifications and levels of recommendations made by the NCCN. Of 91 drug indications analyzed, 83 were newly approved, and eight were withdrawn indications. The NCCN incorporated new indications with similar speed regardless of approval pathway (median of 16 days after accelerated approvals vs 20 days after regular approvals; p = 0.59). Notably, the NCCN added or modified 19 approved indications (22.3%) before FDA approval. Additionally, the NCCN was faster to incorporate approvals than to remove or modify withdrawn indications from its guidelines (19 days vs. 57 days, p = 0.014). Following the official FDA withdrawal of the eight indications in our data set, the NCCN removed only three (37.5%) from its guidelines and continued to recommend five (62.5%) withdrawn indications. Of these withdrawn indications, the NCCN downgraded three (37.5%) in recommendation level and left two (25%) unmodified, endorsing these two with a Category 2 A recommendation. We found that the NCCN rapidly incorporated new FDA-approved indications but, in contrast, delayed updating FDA-withdrawn indications and removed them from guidelines in only a minority of cases. This work highlights a systemic pattern that may drive financial toxicity and suboptimal patient care, underscoring the need for two bodies for the optimal practice of oncologic medicine: one that guides clinicians on all potential treatment options without informing reimbursement coverage, and one that works to usher in cost-effective, evidence-based care to the US market. • The NCCN rapidly incorporated new FDA-approved indications into its guidelines, and in over a fifth of cases, incorporation preceded approval. • The NCCN updated FDA-withdrawn indications after a significant delay following the announcement of the FDA’s desire to remove an indication from the market. • The NCCN removed withdrawn indications from its guidelines in only a minority of cases and continued to recommend some with expert consensus. • These dynamics may drive wasteful systemic healthcare spending, financial toxicity, and subpar patient care.