FDA accepts sNDA for Onivyde + chemotherapy to treat metastatic pancreatic ductal adenocarcinoma
The FDA has accepted a supplemental new drug application (sNDA) seeking approval of the NALIRIFOX regimen comprised of irinotecan liposome injection (Onivyde) plus 5-fluorouracil (5-FU), leucovorin, and oxaliplatin as a first-line treatment for patients with metastatic pancreatic ductal adenocarcinoma (PDAC)
The sNDA was supported by data from the phase III NAPOLI 3 trial (NCT04083235), which showed that NALIRIFOX provided a statistically significant improvement in overall survival (OS) and progression-free survival (PFS) vs nab-paclitaxel (Abraxane) plus gemcitabine. The FDA has set a target action date of February 13, 2024, under the Prescription Drug User Fee Act.
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