Metastatic Pancreatic Cancer Treatment NALIRIFOX Receives FDA Approval

On February 13, 2024, the U.S. Food and Drug Administration (FDA) approved, NALIRIFOX, a new treatment for metastatic pancreatic adenocarcinoma. This treatment has been clinically proven to improve the survival of patients with this advanced diagnosis. This is the first new treatment approved for metastatic pancreatic cancer since 2013.


NALIRIFOX is a new chemotherapy treatment made up of several different chemotherapy drugs: oxaliplatin, fluorouracil, and leucovorin. All of these treatments have previously been approved by the FDA. However, this is the first time they are being used in combination to treat metastatic pancreatic cancer. 

The new chemotherapy cocktail was approved by the FDA following several clinical trials, including a recent study done in 2023 to test the efficacy of the new treatment in comparison to others available to patients with metastatic pancreatic cancer. According to The Lancet, the study covered 18 countries across five continents and included nearly 800 participants between the ages of 20 and 85. 

The study demonstrated several advantages of the new treatment. According to Ipsen, the median overall survival rate for patients taking NALIRIFOX was about 11 months versus the 9-month survival rate for patients taking the alternative treatment. According to Ipsen, NALIRIFOX also improved the progression-free survival rate of patients by about seven months versus the alternative treatment, which only gave patients about five and a half months of progression-free survival. NALIRIFOX also had an objective response rate of about 41% versus the 36% response rate of the alternative treatment. 

How Did NALIRIFOX Come to Be? 

NALIRIFOX was engineered by Ipsen, a biopharmaceutical company that focuses on “highly unmet medical needs.” In 2020, the FDA granted the company fast-track designation, which expedites the process of designing and approving new medication to treat serious illnesses. From there, Ipsen investigated the combination of chemotherapy drugs that would eventually be known as NALIRIFOX, ultimately leading to its approval. 

Pancreatic cancer, especially metastatic adenocarcinoma, is difficult to treat. Metastatic pancreatic cancer is a form of disease that has spread into other parts of the body, and therefore the cancer is no longer contained in the pancreatic region. The study was designed, according to Ipsen, to address the needs of these patients with this advanced form of pancreatic cancer that have stopped responding to treatment.  

This new chemotherapy treatment is now available for patients, as FDA approval states that the drug is safe and effective for patient use. However, patients seeking out this new treatment should know that insurance companies may not cover the treatment, as FDA approval does not guarantee insurance coverage, according to the National Library of Medicine. For those interested in this new treatment, please speak with your healthcare providers about this treatment option. 

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