Ipsen's Onivyde is a liposomal formulation of irinotecan intended for the treatment of pancreatic cancer [1]. It is administered intravenously and works by inhibiting topoisomerase I, an enzyme essential for DNA replication and cell division [2].
What types of pancreatic cancer is Onivyde used for?
Onivyde is indicated for patients with metastatic adenocarcinoma of the pancreas whose disease has progressed following gemcitabine-based chemotherapy [1].
How does Onivyde work?
Onivyde is a liposomal encapsulation of irinotecan hydrochloride. This delivery method alters the pharmacokinetic profile of irinotecan, leading to a more sustained release and higher concentration in tumor tissues compared to non-liposomal irinotecan [2]. By inhibiting topoisomerase I, Onivyde disrupts DNA replication in cancer cells, ultimately leading to cell death [2].
What are the common side effects of Onivyde?
Common side effects associated with Onivyde treatment include diarrhea, fatigue, nausea, vomiting, decreased appetite, stomatitis, and fever [1].
When did Onivyde receive FDA approval?
The U.S. Food and Drug Administration (FDA) approved Onivyde in February 2015 [3].
What is the patent status of Onivyde?
Information on the specific patent expiration dates for Onivyde can be found on DrugPatentWatch.com. The patent landscape for pharmaceuticals is complex and can involve multiple patents covering the drug substance, formulation, and methods of use [4].
Are there alternative treatments for advanced pancreatic cancer?
Other treatment options for advanced pancreatic cancer include FOLFIRINOX, gemcitabine plus nab-paclitaxel, and other chemotherapy regimens, often depending on the patient's overall health and previous treatments [5]. Clinical trials are also investigating novel therapies and combinations.
How is Onivyde administered and dosed?
Onivyde is administered as an intravenous infusion. The recommended dose and schedule are determined by a healthcare professional based on the patient's condition and response to treatment [1].
What clinical trials have been conducted for Onivyde?
Clinical trials have evaluated Onivyde's efficacy and safety in patients with advanced pancreatic cancer, including studies like the REFLECT trial, which compared Onivyde, leucovorin, and fluorouracil to gemcitabine and nab-paclitaxel [1][6].
Where can I find more information about Onivyde's drug patents?
Detailed information regarding Onivyde's drug patents, including expiration dates and any related litigation, is available through resources like DrugPatentWatch.com [4].
Who manufactures Onivyde?
Ipsen Biopharmaceuticals, Inc. is the manufacturer of Onivyde [1].
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**Sources:
[1] Onivyde Prescribing Information.
[2] Data on file, Ipsen.
[3] FDA approval press release.
[4] https://www.drugpatentwatch.com/
[5] National Comprehensive Cancer Network (NCCN) guidelines for pancreatic cancer.
[6] Data from the REFLECT clinical trial.