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    Association details:
    Biomarker:No biomarker
    Cancer:Pancreatic Adenocarcinoma
    Drug:5-fluorouracil (Thymidylate synthase inhibitor) +
    leucovorin calcium (Folate analog) +
    Onivyde (nanoliposomal irinotecan) (Topoisomerase I inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    European Medicines Agency
    Published date:
    10/14/2016
    Excerpt:
    Treatment of metastatic adenocarcinoma of the pancreas, in combination with 5 fluorouracil (5 FU) and leucovorin (LV), in adult patients who have progressed following gemcitabine based therapy.
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    FDA
    Published date:
    10/22/2015
    Excerpt:
    ONIVYDE is a topoisomerase inhibitor indicated, in combination with fluorouracil and leucovorin, for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.
    Evidence Level:
    Sensitive: A2 - Guideline
    New
    Source:
    NCCN
    Excerpt:
    Pancreatic Adenocarcinoma: Preferred Regimens…5-FU + leucovorin + liposomal irinotecan…
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Ipsen Press Release
    Title:

    Ipsen receives FDA Fast Track designation for liposomal irinotecan (ONIVYDE®) as a first-line combination treatment for metastatic pancreatic cancer

    Published date:
    06/17/2020
    Excerpt:
    Ipsen...announced the United States Food and Drug Administration (FDA) has granted the company Fast Track designation for the investigational use of liposomal irinotecan (ONIVYDE) in combination with 5- fluorouracil/leucovorin (5-FU/LV) and oxaliplatin (OX) together, known as NALIRIFOX for patients with previously untreated, unresectable, locally advanced and metastatic pancreatic ductal adenocarcinoma (PDAC).
    Secondary therapy:
    oxaliplatin
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Eur J Cancer
    Title:

    NAPOLI-1 phase 3 study of liposomal irinotecan in metastatic pancreatic cancer: Final overall survival analysis and characteristics of long-term survivors

    Published date:
    02/01/2019
    Excerpt:
    Patients with mPDAC were randomised to receive nal-IRI + 5-FU/LV (n = 117), nal-IRI (n = 151), or 5-FU/LV (n = 149) for the first 4 weeks of 6-week cycles....The overall survival advantage for nal-IRI+5-FU/LV vs 5-FU/LV was maintained from the original nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1) analysis (6.2 vs 4.2 months, respectively; HR, 0.75; 95% confidence interval: 0.57–0.99). Median progression-free survival, objective response rate and disease control rate also favoured nal-IRI+5-FU/LV therapy.
    DOI:
    10.1016/j.ejca.2018.12.007
    Trial ID:
    NAPOLI-1