The U.S. Food and Drug Administration (FDA) has given its approval to Ipsen’s Onivyde (irinotecan liposome injection) in combination with oxaliplatin, fluorouracil, and leucovorin (NALIRIFOX) as a first-line treatment for adults with metastatic pancreatic adenocarcinoma (mPDAC).
Previously, the FDA had approved the use of Onivyde in combination with fluorouracil and leucovorin for mPDAC patients who had experienced disease progression with gemcitabine-based therapy.
The approval was based on the results from the NAPOLI 3 trial, a Phase III pivotal trial. This trial involved 770 adults with mPDAC who had not received any previous treatment. The trial was conducted at 187 trial sites across 18 countries.
The NAPOLI 3 trial demonstrated that NALIRIFOX provided a significant improvement in median overall survival compared to nab-paclitaxel and gemcitabine-treated patients. The median overall survival for NALIRIFOX was 11.1 months, while for nab-paclitaxel and gemcitabine-treated patients, it was 9.2 months (hazard ratio 0.84). Additionally, NALIRIFOX also showed a significant improvement in median progression-free survival. The median progression-free survival for NALIRIFOX was 7.4 months, whereas for nab-paclitaxel and gemcitabine-treated patients, it was 5.6 months (hazard ratio 0.70).
Julie Fleshman, the president and CEO of Pancreatic Cancer Action Network, expressed hope with the approval, stating that with each new treatment option, there is increased hope for future pancreatic cancer patients. For those currently living with pancreatic cancer, this approval means they may have more quality time with their loved ones.
Metastatic pancreatic cancer is a challenging disease to treat, and the prognosis for patients diagnosed with this condition is often poor. The approval of Onivyde in combination with NALIRIFOX provides a new option for patients who have not yet received any treatment. This combination therapy has shown significant improvements in both overall survival and progression-free survival, offering hope to those affected by this aggressive form of cancer.
Onivyde works by delivering irinotecan, an anti-cancer drug, directly to tumor cells using a liposome delivery system. This targeted approach enhances the efficacy of the drug while minimizing systemic side effects. When combined with oxaliplatin, fluorouracil, and leucovorin, Onivyde has shown promising results in the treatment of mPDAC.
Pancreatic cancer is one of the deadliest forms of cancer, with a five-year survival rate of less than 10 percent. Finding effective treatment options for this disease is crucial in improving patient outcomes and quality of life. The FDA’s approval of Onivyde in combination with NALIRIFOX marks a significant milestone in the fight against metastatic pancreatic cancer.
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1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it