Ipsen has developed a groundbreaking treatment called Onivyde® (irinotecan liposome injection) in combination with oxaliplatin, fluorouracil, and leucovorin (NALIRIFOX) for adults with metastatic pancreatic adenocarcinoma (mPDAC) as a first-line therapy.
The Phase III NAPOLI 3 trial results mark a significant advancement in the treatment of mPDAC, showing positive outcomes compared to the currently approved nab-paclitaxel and gemcitabine regimen.
This approval establishes the Onivyde (NALIRIFOX) regimen as a potential new standard-of-care option, offering proven survival benefits for individuals with mPDAC in the U.S.
Onivyde works by inhibiting an enzyme called topoisomerase I, crucial for DNA replication in cancer cells. Encapsulated in liposomes, irinotecan in Onivyde accumulates in tumours and releases gradually over time.
The treatment is administered via intravenous infusion every two weeks, with dosage adjustments as needed. Onivyde can now be prescribed immediately in the U.S. for eligible treatment-naïvoe individuals or those who have undergone gemcitabine-based therapy.
PDAC is the most prevalent type of pancreatic cancer, with a significant number of diagnoses annually in the U.S. and globally. Often detected late due to nonspecific symptoms, PDAC typically progresses rapidly to metastatic stages, resulting in poor prognoses and low survival rates.
Metastatic pancreatic adenocarcinoma poses considerable challenges in treatment, with limited options available.
Onivyde stands out as the only FDA-approved regimen demonstrating efficacy in multiple phase III trials across different lines of therapy for mPDAC.
