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The FDA approved (Onivyde) in combination with oxaliplatin, leucovorin, and fluorouracil (NALIRIFOX) for the first-line treatment of metastatic pancreatic adenocarcinoma, the agency announced on Tuesday.

Approval was based on results from the phase III of 770 patients with metastatic pancreatic adenocarcinoma who had not previously received chemotherapy in the metastatic setting. Patients in the study were randomized to receive either NALIRIFOX or gemcitabine plus nab-paclitaxel (Abraxane).

Median overall survival -- the study's primary endpoint -- reached 11.1 months in the NALIRIFOX arm versus 9.2 months in the gemcitabine plus nab-paclitaxel arm (HR 0.84, 95% CI 0.71-0.99, P=0.0403).

Treatment with NALIRIFOX improved median progression-free survival (7.4 vs 5.6 months, respectively; HR 0.70, 95% CI 0.59-0.85, P=0.0001), and led to a favorable overall response rate as well (41.8% vs 36.2%).

"These results support NALIRIFOX as a new reference regimen for the first-line treatment of patients with metastatic pancreatic cancer and, hopefully, something we can build off of in the future," said study investigator Zev Wainberg, MD, of the UCLA Medical Center-Santa Monica in California, speaking at the 2023 Gastrointestinal Cancers Symposium, when the primary findings were first presented.

The most common adverse events with NALIRIFOX (≥20% with a difference between arms of ≥5% for all grades or ≥2% for grades 3/4 events) were diarrhea, fatigue, nausea, vomiting, decreased appetite, abdominal pain, mucosal inflammation, constipation, and decreased weight. The most common laboratory abnormalities (≥10% grade 3/4) were decreases in neutrophils, potassium, lymphocytes, and hemoglobin.

The recommended irinotecan liposome dose of 50 mg/m² is administered by IV infusion over 90 minutes every 2 weeks, and should precede the other drugs in the regimen.

In 2015, the FDA approved irinotecan liposome in combination with fluorouracil and leucovorin to treat patients with metastatic pancreatic cancer whose disease has progressed after gemcitabine-based chemotherapy.

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