FDA Approval Insights: NALIRIFOX in Metastatic Pancreatic Cancer

Welcome to OncLive On Air^®! I’m your host today, Ashling Wahner.

OncLive On Air is a podcast from OncLive^®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, sponsored by Ipsen, we had the pleasure of speaking with Zev A. Wainberg, MD, about the FDA approval of first-line NALIRIFOX (irinotecan liposome [Onivyde], oxaliplatin, 5-fluorouracil, and leucovorin) for patients with metastatic pancreatic adenocarcinoma. Dr Wainberg is a professor of medicine at the University of California, Los Angeles (UCLA), as well as codirector of the UCLA Gastrointestinal Oncology Program.

On February 13, 2024, the FDA approved NALIRIFOX for the frontline treatment of patients with metastatic pancreatic adenocarcinoma. This regulatory decision was backed by findings from the phase 3 NAPOLI 3 trial (NCT04083235), in which patients who received NALIRIFOX achieved a median overall survival of 11.1 months (95% CI, 10.0-12.1) vs 9.2 months (95% CI, 8.3-10.6) in patients who received gemcitabine plus nab-paclitaxel (Abraxane).

In our exclusive interview, Dr Wainberg discussed the significance of this approval, key data from NAPOLI 3, and the potential evolution of NALIRIFOX’s role in the treatment of patients with pancreatic cancer.

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