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Ipsen’s Onivyde is now FDA approved as a first-line treatment for metastatic pancreatic cancer, triggering a milestone payment to Merrimack Pharmaceuticals, the drug’s original developer. Merrimack plans to dissolve operations but its shareholders will receive payouts from the Ipsen payment. ....
The FDA has approved irinotecan liposome (Onivyde) with oxaliplatin, fluorouracil, and leucovorin, for the frontline treatment of metastatic pancreatic adenocarcinoma. ....
The FDA has accepted a supplemental new drug application seeking approval of the NALIRIFOX regimen comprised of irinotecan liposome injection plus 5-fluorouracil, leucovorin, and oxaliplatin as a first-line treatment for patients with metastatic pancreatic ductal adenocarcinoma. ....
Supplemental New Drug Application (sNDA) submission based on the NAPOLI 3 Phase III trial1Approval would represent expansion of treatment options in an aggressive and difficult-to-treat cancer with few ....
Single-agent liposomal irinotecan resulted in a similar median overall survival and progression-free survival to that achieved with topotecan in patients with small cell lung cancer that had progressed on or following frontline platinum-based chemotherapy. ....