Onivyde (irinotecan liposome injection) is a chemotherapy drug used to treat pancreatic cancer. It was approved by the U.S. Food and Drug Administration (FDA) for use in combination with fluorouracil and leucovorin in patients with metastatic adenocarcinoma of the pancreas whose disease has progressed following gemcitabine-based therapy [1].
What is Onivyde specifically approved for?
Onivyde is approved for adults with pancreatic cancer that has spread and worsened after prior treatment with gemcitabine [1]. It is administered intravenously [2].
What are the ingredients in Onivyde?
Onivyde is a liposome-eluting formulation of irinotecan hydrochloride. The active ingredient is irinotecan, which is encapsulated within lipid nanoparticles [1].
When was Onivyde first approved?
Onivyde received its initial FDA approval on October 24, 2015 [1].
What are the potential side effects of Onivyde?
Common side effects of Onivyde include diarrhea, fatigue, neutropenia (low white blood cell count), nausea, vomiting, decreased appetite, stomatitis (mouth sores), and pyrexia (fever) [1]. Severe diarrhea and neutropenia are particularly serious risks [2].
How does Onivyde work?
Irinotecan is a topoisomerase I inhibitor. It works by interfering with a specific enzyme in cancer cells that is necessary for DNA replication and cell division, ultimately leading to cell death [1]. The liposome formulation is designed to prolong the circulation of irinotecan in the body [2].
What is the patent status of Onivyde?
Information on specific patents for Onivyde and their expiration dates can be found on DrugPatentWatch.com [3]. Patent exclusivity is a crucial factor for pharmaceutical companies and the introduction of generic or biosimilar alternatives.
How does Onivyde compare to other pancreatic cancer treatments?
Onivyde is indicated for patients whose disease has progressed after gemcitabine-based therapy, suggesting it is used in later lines of treatment. Other pancreatic cancer treatments may include surgery, radiation therapy, and different chemotherapy regimens [1].
What clinical trials led to Onivyde's approval?
Onivyde's approval was based on results from the pivotal Phase 3 metastatic pancreatic cancer trial, known as NAPOLI-1. This study demonstrated improved overall survival and progression-free survival in patients treated with Onivyde in combination with fluorouracil and leucovorin compared to those receiving fluorouracil and leucovorin alone [1].
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Sources
1. DrugPatentWatch.com
2. FDA approval documents for Onivyde
3. DrugPatentWatch.com