(Boursier.com) — Ipsen announces that the American authorities (Food and Drug Administration, FDA) have approved the additional indication of Onivyde (irinotecan liposomal injection) in combination with oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) as first-line treatment in adult patients with metastatic pancreatic adenocarcinoma (mPDAC).
This is the second approval of an Onivyde regimen in metastatic pancreatic adenocarcinoma, following the 2015 FDA approval of Onivyde in combination with fluorouracil and leucovorin following disease progression after a treatment involving gemcitabine.
“The results of the Phase III NAPOLI 3 trial represent the first positive data for an experimental protocol in the first-line treatment of metastatic pancreatic adenocarcinoma, compared to the currently approved regimen with nab-paclitaxel and gemcitabine” declared Christelle Huguet, Executive Vice President and Director of Research and Development, Ipsen. “With today’s approval, Onivyde’s regimen may well serve as a new gold standard treatment option, with demonstrated survival benefits for people with metastatic pancreatic adenocarcinoma in the United States.”
Pancreatic adenocarcinoma (PDAC) is the most common form of pancreatic cancer. Each year, more than 60,000 people are diagnosed in the United States and nearly 500,000 people worldwide. Since patients with metastatic PDAC do not have any specific symptoms in the early stage, this cancer is often detected late and especially after the disease has spread to other parts of the body (metastatic or stage IV).
Considered a complex cancer due to rapid tumor progression, limited genetic targets and numerous resistance mechanisms, metastatic PDAC is associated with a particularly poor prognosis, since less than 20% of affected people survive more than a year . Pancreatic cancer has the lowest 5-year survival rate of all cancer types worldwide and in the United States.
“The management of metastatic pancreatic adenocarcinoma is complex, as the treatment options available are very limited…Given the reality of this aggressive form of cancer and the complexity of the disease, each advance in the therapeutic landscape will help significantly improve patient outcomes,” said Dr. Zev Wainberg, Professor of Medicine and Co-Director of the Digestive Oncology Program at the University of California, Los Angeles. “The approval of this Onivyde regimen marks a turning point for people with metastatic pancreatic adenocarcinoma, their families and their healthcare providers, while the NAPOLI 3 trial demonstrated benefits in survival compared to the current reference treatment.”
“We welcome the decision of the American health authorities to approve the NALIRIFOX regimen in this new indication. Each time a new treatment is approved, hope grows for those who will receive a diagnosis in the future like people currently living with pancreatic cancer, to spend more time with their loved ones,” said Julie Fleshman, JD, MBA, President and CEO of the Pancreatic Cancer Action Network (PanCAN), an advocacy association for which aims to provide patients and their caregivers with evidence-based information and resources, and to advance research to improve the health status of patients. “We would like to express our sincere gratitude to the patients who participated in this clinical trial, as they play a crucial role in advancing treatments for pancreatic cancer.”
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