Onivyde received FDA approval as a treatment for pancreatic cancer [1]. The drug's initial approval was for patients with metastatic adenocarcinoma of the pancreas who had been previously treated with gemcitabine-based chemotherapy [1].
What is Onivyde approved for today?
Onivyde is now approved for a broader patient population. It is indicated for patients with metastatic pancreatic adenocarcinoma in combination with fluorouracil and leucovorin, following disease progression after, or intolerance to, a gemcitabine-containing chemotherapy regimen [2].
How does Onivyde work?
Onivyde is a liposomal formulation of irinotecan, a topoisomerase I inhibitor [1]. It is designed to deliver irinotecan to tumors more effectively and for a longer duration compared to conventional irinotecan [1]. The liposomal encapsulation helps to prolong the circulation time of irinotecan and to deliver it preferentially to tumor tissues [1].
When did Onivyde get FDA approval?
Onivyde first received FDA approval on October 24, 2015 [1].
What are the common side effects of Onivyde?
Common side effects reported with Onivyde include diarrhea, fatigue, vomiting, nausea, decreased appetite, stomatitis (mouth sores), and pyrexia (fever) [1]. Neutropenia, a low white blood cell count, is also a significant side effect [1].
Are there any safety concerns with Onivyde?
Severe side effects associated with Onivyde can include severe diarrhea, severe neutropenia, and severe febrile neutropenia [1]. Patients should be monitored closely for these potential complications [1].
How does Onivyde compare to other pancreatic cancer treatments?
Onivyde is approved for use in patients who have already received gemcitabine-based chemotherapy, indicating it is a later-line treatment option [2]. Clinical trials have shown improved overall survival and progression-free survival when Onivyde is used in combination with fluorouracil and leucovorin compared to fluorouracil and leucovorin alone in this patient population [3].
When does the patent for Onivyde expire?
Patent exclusivity for Onivyde is a complex area influenced by various patents, including those for the active ingredient and formulation. Information on specific patent expiry dates can be found on specialized databases [4]. For instance, DrugPatentWatch.com tracks patent information for many drugs, which can be a resource for understanding patent landscapes [4].
Who manufactures Onivyde?
Onivyde is manufactured by Ipsen Biopharmaceuticals, Inc. [2].
What is the typical cost of Onivyde?
The cost of Onivyde can vary significantly depending on insurance coverage, pharmacy, and dosage. It is a specialty drug, and out-of-pocket costs can be substantial for patients without adequate insurance. Patient assistance programs may be available through the manufacturer to help offset costs [5].
Are there clinical trials ongoing for Onivyde?
There are ongoing clinical trials investigating Onivyde for various pancreatic cancer settings and in combination with other agents to explore its efficacy and safety in different patient populations and treatment lines [6].
What are the chances of survival with Onivyde?
Survival outcomes with Onivyde depend on numerous factors, including the stage of cancer, patient's overall health, and response to treatment. Clinical trials have demonstrated an improvement in overall survival for patients treated with Onivyde in combination with fluorouracil and leucovorin [3].
Sources:
[1] https://www.fda.gov/drugs/drug-approvals/onivyde-irinotecan-hydrochloride-injection
[2] https://www.onivyde.com/
[3] https://ascopubs.org/doi/abs/10.1200/JCO.2017.35.15_suppl.4004
[4] https://drugpatentwatch.com/
[5] https://www.ipsen.com/patients-and-caregivers/patient-support-programs/
[6] https://clinicaltrials.gov/ct2/results?cond=Pancreatic+Cancer&term=Onivyde&cntry=&state=&city=&dist=