pharmaphorum February 14, 2024
Ipsen has won FDA approval for first-line use of its pancreatic cancer therapy Onivyde, saying it is now part of a potential new “standard-of-care” for patients.
Onivyde (pegylated liposomal irinotecan) given as part of the NALIRIFOX regimen alongside oxaliplatin, 5-fluorouracil (5-FU) and leucovorin can now be used to treat previously untreated metastatic pancreatic adenocarcinoma (mPDAC), according to the US regulator. It is the first new treatment for this patient group in more than a decade.
In the phase 3 NAPOLI-3 study, the Onivyde regimen showed an improvement in overall survival (OS) and progression-free survival (PFS) when compared to the standard first-line treatment regimen of Bristol-Myers Squibb’s Abraxane (nab-paclitaxel) plus gemcitabine.
There was a statistically significant improvement in OS of 11.1...
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