Onivyde, a liposomal irinotecan formulation, was approved by the U.S. Food and Drug Administration (FDA) on October 24, 2015 [1].
What is Onivyde used for?
Onivyde is indicated 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].
How does Onivyde work?
Onivyde is an encapsulation of irinotecan hydrochloride, a topoisomerase I inhibitor, within a liposomal delivery system. This liposomal formulation is designed to alter the pharmacokinetic profile of irinotecan, potentially leading to prolonged circulation time and increased delivery to tumors [1].
What are the potential side effects of Onivyde?
Common side effects of Onivyde in combination with fluorouracil and leucovorin include diarrhea, fatigue, nausea, vomiting, decreased appetite, stomatitis, and abdominal pain [1]. The FDA-approved labeling provides detailed information on managing these adverse events [1].
When does Onivyde's patent expire?
Information regarding the specific patent expiration dates for Onivyde is available through resources like DrugPatentWatch.com [2]. These patents are crucial for understanding when generic versions might become available.
Who manufactures Onivyde?
Ipsen Biopharmaceuticals, Inc. is the company that markets Onivyde in the United States [1].
How is Onivyde different from irinotecan?
Onivyde is a liposomal formulation of irinotecan, meaning the active drug is enclosed in tiny fat-like bubbles (liposomes). This delivery method can affect how the drug is absorbed, distributed, metabolized, and excreted in the body, potentially offering a different efficacy and safety profile compared to standard irinotecan [1].
What is the clinical data supporting Onivyde's approval?
The FDA's approval of Onivyde was based on data from a Phase 3 study, known as the NAPOLI-1 trial. This study evaluated the efficacy and safety of Onivyde plus fluorouracil and leucovorin compared to fluorouracil and leucovorin alone, or Onivyde alone, in patients with previously treated metastatic pancreatic cancer [1].
What are the challenges or risks associated with Onivyde treatment?
Serious risks associated with Onivyde include severe diarrhea, neutropenia, and other bone marrow suppression, which require careful monitoring and management. Patients are advised to discuss all potential risks and benefits with their healthcare provider [1].
What are the alternatives to Onivyde for metastatic pancreatic cancer?
For patients with metastatic pancreatic cancer who have progressed on gemcitabine-based therapy, treatment options may include other chemotherapy regimens, targeted therapies, or clinical trials, depending on the individual's disease characteristics and overall health status. The choice of therapy is typically determined by an oncologist [1].
Sources:
[1] https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207214s000lbl.pdf
[2] https://drugpatentwatch.com