Work

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

Year: 2026

Type: article

Abstract: OBJECTIVE: To characterize the speed and nature of National Comprehensive Cancer Network (NCCN) guideline updates following Food and Drug Administration (FDA) approvals and withdrawals. METHODS: 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. RESULTS: Of 91 drug indications analyzed, 83 were newly approved, and eight were withdrawn indications.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 Additionally, the NCCN was faster to incorporate approvals than to remove or modify withdrawn indications from its guidelines (19 days vs. 57 days, p = 0.014).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 %). Of these five withdrawn indications, the NCCN downgraded three (37.5 %) in recommendation level and left two (25 %) unmodified, endorsing them with a Category 2 A recommendation. CONCLUSIONS & POLICY SUMMARY: We found that the NCCN rapidly incorporated new FDA-approved indications but, delayed updating FDA-withdrawn indications, removing them from guidelines in only a minority of cases.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.

Source: Journal of Cancer Policy

DOI: 10.1016/j.jcpo.2026.100717

Authors: Christopher L. Rios, Alyson Haslam, Vinay Prasad

Institution: University of California, San Francisco

Language: English

Topic: Clinical practice guidelines implementation

Subfield: Public Health, Environmental and Occupational Health

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: hybrid

Estimated APC paid: $2,760