Onivyde FDA Approval History
Last updated by Judith Stewart, BPharm on Feb 13, 2024.
FDA Approved: Yes (First approved October 22, 2015)
Brand name: Onivyde
Generic name: irinotecan liposomal
Dosage form: Injection
Company: Ipsen Biopharmaceuticals, Inc.
Treatment for: Pancreatic Cancer
Onivyde (irinotecan liposome injection) is a liposomal formulation of the topoisomerase I inhibitor irinotecan used in the treatment of pancreatic adenocarcinoma.
- Onivyde is indicated:
- in combination with oxaliplatin, fluorouracil and leucovorin, for the first-line treatment of adult patients with metastatic pancreatic adenocarcinoma.
- in combination with fluorouracil and leucovorin, for the treatment of adult patients with metastatic pancreatic adenocarcinoma after disease progression following gemcitabine-based therapy.
Limitation of Use: Onivyde is not indicated as a single agent for the treatment of patients with metastatic pancreatic adenocarcinoma.
Development timeline for Onivyde
Further information
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