Onivyde, an irinotecan liposome injection, received its initial U.S. Food and Drug Administration (FDA) approval on October 24, 2015 [1]. This approval was for the treatment of patients with metastatic adenocarcinoma of the pancreas after initial therapy with a gemcitabine-based chemotherapy regimen [1].
How does Onivyde work?
Onivyde is a liposomal formulation of irinotecan, a topoisomerase I inhibitor [1]. In this formulation, irinotecan is encapsulated within tiny lipid spheres called liposomes [1]. This encapsulation is designed to alter the drug's pharmacokinetic profile, potentially leading to sustained release and improved delivery to tumor sites [1].
When was Onivyde approved for pancreatic cancer?
Onivyde was approved by the FDA on October 24, 2015, specifically for patients with metastatic pancreatic adenocarcinoma who had previously undergone gemcitabine-based chemotherapy [1]. This represented a new treatment option for a patient population with limited therapeutic choices [1].
What is Onivyde used for now?
Following its initial approval, Onivyde has been investigated and approved for use in combination with other agents. In February 2021, the FDA approved Onivyde in combination with fluorouracil and leucovorin for patients with metastatic pancreatic adenocarcinoma, following disease progression after a gemcitabine-based chemotherapy regimen [2]. This combination therapy targets pancreatic cancer in a later stage of the disease [2].
What are the side effects of Onivyde?
Common side effects reported with Onivyde include diarrhea, fatigue, vomiting, nausea, decreased appetite, stomatitis (mouth sores), and fever [1]. The liposomal formulation may also influence the side effect profile compared to non-liposomal irinotecan [1].
What is the patent status of Onivyde?
Information regarding specific patent expiry dates for Onivyde can be found on specialized resources. DrugPatentWatch.com provides a database of drug patents and their expected expiration timelines [3].
What are the alternatives to Onivyde for pancreatic cancer?
Treatment options for metastatic pancreatic cancer depend on the stage of the disease and prior therapies. For patients who have progressed after gemcitabine-based chemotherapy, Onivyde in combination with fluorouracil and leucovorin is an option [2]. Other treatment regimens and investigational therapies may also be considered based on individual patient circumstances and clinical trial availability.
Who manufactures Onivyde?
Onivyde is manufactured by Ipsen Biopharmaceuticals, Inc. [2].
What clinical data supports Onivyde's approval?
The initial FDA approval of Onivyde was based on data from a Phase 3 study, the NAPOLI-1 trial [1]. This study demonstrated a statistically significant improvement in overall survival for patients treated with liposomal irinotecan plus fluorouracil and leucovorin, or with liposomal irinotecan alone, compared to those receiving fluorouracil and leucovorin alone [1]. The subsequent approval for combination therapy in 2021 was also supported by clinical trial data [2].
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1. U.S. Food and Drug Administration. (2015, October 21). *FDA approves Onivyde for pancreatic cancer. https://www.fda.gov/drugs/resources-you-drugs/fda-approves-onivyde-pancreatic-cancer
2. U.S. Food and Drug Administration. (2021, February 4). FDA approves Onivyde combination for pancreatic cancer. https://www.fda.gov/drugs/resources-you-drugs/fda-approves-onivyde-combination-pancreatic-cancer
3. DrugPatentWatch.com.