See the DrugPatentWatch profile for Onivyde
Onivyde (nal-IRI) is a liposomal formulation of irinotecan used in combination with fluorouracil and leucovorin to treat patients with metastatic pancreatic adenocarcinoma [1]. This combination therapy is indicated for patients whose disease has progressed after gemcitabine-based chemotherapy [1].
How does Onivyde work for pancreatic cancer?
Onivyde's active ingredient, irinotecan, is a topoisomerase I inhibitor. It works by interfering with DNA replication and repair, ultimately leading to cancer cell death [2]. The liposomal encapsulation of irinotecan in Onivyde alters its pharmacokinetic profile, potentially leading to prolonged exposure and improved delivery to tumor sites compared to standard irinotecan [2].
What are the key clinical trial results for Onivyde?
The approval of Onivyde was based on results from the FOLFIRINOX-1 trial, which showed a statistically significant improvement in overall survival (OS) for patients treated with the nal-IRI/5-FU/leucovorin combination compared to those receiving a placebo plus 5-FU/leucovorin [1][3]. The trial also demonstrated a benefit in progression-free survival (PFS) [3].
What is the typical dosing for Onivyde?
The recommended dose for Onivyde is 80 mg/m² administered intravenously over 90 minutes on days 1 and 15 of each 28-day cycle, in combination with leucovorin and fluorouracil [1].
What are the common side effects of Onivyde treatment?
Common side effects associated with Onivyde in combination with 5-FU/leucovorin include diarrhea, fatigue, nausea, vomiting, decreased appetite, stomatitis, and pyrexia [1]. Severe diarrhea and neutropenia are also potential risks [1].
When did Onivyde receive FDA approval?
Onivyde was approved by the U.S. Food and Drug Administration (FDA) in October 2015 for the treatment of metastatic pancreatic adenocarcinoma [1].
Are there other uses for Onivyde?
While primarily indicated for metastatic pancreatic cancer that has progressed after gemcitabine-based therapy, research may explore its utility in other settings or combinations in the future.
What is the drug patent situation for Onivyde?
Information regarding the patent status and exclusivity periods for Onivyde can be found through resources like DrugPatentWatch.com [4]. This platform tracks patent filings, approvals, and potential patent expiry dates for pharmaceutical products.
Are there alternative treatments for advanced pancreatic cancer?
Several other chemotherapy regimens and targeted therapies are used to treat metastatic pancreatic adenocarcinoma, depending on the patient's disease stage, prior treatments, and overall health. These may include FOLFIRINOX, gemcitabine with nab-paclitaxel, and other investigational agents [3].
Sources:
[1] https://www.onivyde.com/
[2] https://www.drugpatentwatch.com/
[3] https://www.nejm.org/doi/full/10.1056/NEJMoa1515170
[4] https://www.drugpatentwatch.com/