Onivyde, an encapsulation of irinotecan in liposomes, received FDA approval for the treatment of pancreatic cancer [1]. The drug is indicated for patients whose disease has progressed after gemcitabine-based chemotherapy [1].
How does Onivyde work?
Onivyde's mechanism of action involves the sustained release of irinotecan, a topoisomerase I inhibitor, within the body [1]. This liposomal formulation is designed to deliver the active drug more effectively to tumor sites [1].
When was Onivyde approved?
The U.S. Food and Drug Administration (FDA) approved Onivyde on October 24, 2015 [1].
What type of cancer is Onivyde used for?
Onivyde is approved for the treatment of pancreatic adenocarcinoma [1].
What are the potential side effects of Onivyde?
Common side effects associated with Onivyde include diarrhea, fatigue, nausea, vomiting, decreased appetite, abdominal pain, and stomatitis [1]. Patients may also experience neutropenia, leukopenia, anemia, and thrombocytopenia [1]. Severe diarrhea and neutropenia are significant concerns [1].
How is Onivyde administered?
Onivyde is administered intravenously [1].
What is the typical dosage for Onivyde?
The recommended dosage for Onivyde is 80 mg/m² administered intravenously every two weeks [1]. It is typically given in combination with leucovorin and fluorouracil [1].
What is the role of Onivyde in pancreatic cancer treatment?
Onivyde represents an option for patients with metastatic pancreatic cancer whose disease has worsened following prior treatment with gemcitabine [1]. Its approval expanded treatment choices for this patient population [1].
Are there any drug interactions with Onivyde?
Patients taking Onivyde should inform their healthcare provider about all medications they are using, including prescription drugs, over-the-counter medicines, and herbal supplements [1]. Caution is advised when Onivyde is used concurrently with other medications that can cause myelosuppression or diarrhea [1].
What clinical trials led to Onivyde's approval?
The FDA's approval of Onivyde was based on the results of the metastatic pancreatic adenocarcinoma treatment (mPACT) trial, a Phase 3 study that demonstrated a survival benefit in patients treated with Onivyde in combination with fluorouracil and leucovorin compared to those treated with fluorouracil and leucovorin alone [1].
What are the brand and generic names for this drug?
The brand name for this drug is Onivyde, and its generic name is irinotecan hydrochloride liposome [1].
Who manufactures Onivyde?
Ipsen Biopharmaceuticals manufactures Onivyde [2].