Ipsen’s Onivyde® regimen, a potential new standard-of-care first-line therapy in metastatic pancreatic adenocarcinoma, approved by FDA
IPSEN SA S/ADR (IPSEY)
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Source: GlobeNewswire
Approval based on Phase III NAPOLI 3 clinical trial in which Onivyde® regimen (NALIRIFOX) demonstrated statistically significant superiority and clinically meaningful improvements in overall survival and progression-free survival versus nab-paclitaxel and gemcitabine 1NAPOLI 3 represents the first positive Phase III trial in first-line metastatic pancreatic adenocarcinoma (mPDAC) to demonstrate superior overall survival versus the currently approved regimen of nab-paclitaxel and gemcitabine1Onivyde is the only FDA-approved treatment regimen to demonstrate efficacy in two Phase III trials across lines of therapy in mPDAC1,2 PARIS, FRANCE, 13 February 2024 - Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application for Onivyde® (irinotecan liposome injection) plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) as a first-line treatment in adults living with metastatic pancreatic adenoc
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