The US Food and Drug Administration approved Ipsen‘s supplemental new drug application for the Onivyde (irinotecan liposome injection) combination regimen (NALIRIFOX) as a first-line treatment for metastatic pancreatic adenocarcinoma (mPDAC) in adults.
The treatment is indicated for use with oxaliplatin, fluorouracil and leucovorin.
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It is the second FDA approval for an Onivyde regimen in mPDAC, expanding treatment options for patients.
In 2015, the regulator approved Onivyde plus fluorouracil and leucovorin in patients experiencing disease progression following gemcitabine-based therapy.
The latest approval is based on findings from the Phase III NAPOLI 3 clinical trial.
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The open-label, randomised trial enrolled 770 individuals across 187 sites in 18 countries.
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By GlobalDataThe trial met its primary and secondary endpoints, showing improvements in survival rates for subjects treated with the Onivyde regimen compared to those receiving nab-paclitaxel and gemcitabine.
Patients treated with the Onivyde regimen, NALIRIFOX, experienced a median overall survival of 11.1 months, notably longer than the 9.2 months observed in patients treated with nab-paclitaxel and gemcitabine.
The Onivyde combination also led to a median progression-free survival of 7.4 months, compared to 5.6 months under the alternative treatment.
The objective response rate for the NALIRIFOX regimen was 41.8%, against the 36.2% rate for those receiving nab-paclitaxel and gemcitabine.
Despite the potential for serious adverse events such as fatal neutropenic fever and severe diarrhoea, the safety profile of the Onivyde regimen was deemed manageable.
Ipsen Research and Development EVP and head Christelle Huguet stated: “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.”
Ipsen holds sole rights to market Onivyde in the US for existing and future indications while Servier will commercialise the therapy outside the US and Taiwan.
In August 2023, Ipsen received FDA approval for Sohonos (palovarotene) capsules to treat fibrodysplasia ossificans progressiva.
