Ipsen said that the US Food and Drug Administration (FDA) has approved the supplemental new drug application for Onivyde (irinotecan liposome injection) regimen for adults with metastatic pancreatic adenocarcinoma (mPDAC).

Onivyde is a cancer therapy that inhibits an enzyme called topoisomerase 1, which is involved in replicating cell DNA needed to make new cells.

The US FDA has approved Onivyde plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) as a potential new standard-of-care first-line of treatment for mPDAC.

This is the second approval for an Onivyde regimen in mPDAC, following its US approval in 2015 of Onivyde plus fluorouracil and leucovorin after disease progression with gemcitabine-based treatment.

Ipsen executive vice president and research and development head Christelle Huguet said: “The results from the Phase 3 NAPOLI 3 trial represent the first positive data for an investigational regimen in first-line metastatic pancreatic adenocarcinoma versus the currently approved nab-paclitaxel and gemcitabine regimen.

“With today’s approval, this Onivyde (NALIRIFOX) regimen can now offer a potential new standard-of-care treatment option with proven survival benefits for people living with metastatic pancreatic adenocarcinoma in the US.”

The approval was based on efficacy and safety data from the Phase 3 NAPOLI 3 trial that assessed 770 mPDAC people between the ages of 20 and 85 without prior treatment.

The randomised, open-label trial met the primary and secondary endpoints.

NALIRIFOX showed statistically significant superiority and clinically meaningful changes in overall survival and progression-free survival against nab-paclitaxel and gemcitabine.

The Onivyde regimen also demonstrated a statistically significant improvement in median progression-free survival (mPFS) compared to nab-paclitaxel and gemcitabine-treated patients.

Additionally, the objective response rate was greater for patients treated with the NALIRIFOX regimen than for patients treated with nab-paclitaxel and gemcitabine.

Furthermore, the Onivyde regimen’s safety profile was manageable and consistent with the individual profiles of the treatment components.

Ipsen received FDA fast-track designation for Onivyde as a first-line combination treatment for mPDAC in 2020.