NALIRIFOX earns NCCN Category 1 status; real-world and subgroup data support use

The NALIRIFOX regimen (Onivyde + oxaliplatin + 5-FU/leucovorin) received FDA approval in February 2024 for first-line metastatic pancreatic ductal adenocarcinoma (mPDAC) and was designated a Category 1 treatment option by the NCCN in early 2025. At ASCO 2025, subgroup analyses from the NAPOLI-3 trial demonstrated that patients with good performance status and dose modifications achieved a median overall survival of 19.5 months. Comparative analyses confirmed similar or improved efficacy versus FOLFIRINOX with fewer hematologic but more gastrointestinal toxicities. Clinicians highlighted the need for careful UGT1A1 genotyping and toxicity management. Additionally, pharmacoeconomic analyses suggested NALIRIFOX offers a cost-effective alternative to gemcitabine/nab-paclitaxel. Real-world adoption has been supported by updated ESMO and ASCO guidance encouraging selection based on tolerability and biomarker profiles. These developments reinforce NALIRIFOX as a frontline standard, particularly in patients unsuitable for FOLFIRINOX.‍

Citation: https://www.empr.com/home/news/onivyde-regimen-approved-as-first-line-tx-for-metastatic-pancreatic-adenocarcinoma/

Implication: NALIRIFOX cements place among preferred first-line mPDAC options, especially for tailored dosing strategies.

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