Onivyde

Onivyde is the brand name for nal-IRI, a pegylated liposomal formulation of the chemotherapy agent irinotecan. By encapsulating irinotecan in a lipid vesicle, the formulation aims to alter pharmacokinetics to prolong circulation and improve delivery to tumors.

Irinotecan is a topoisomerase I inhibitor. In Onivyde, the liposomal carrier releases irinotecan, which is converted in the body to SN-38, the active metabolite that damages cancer cell DNA and inhibits replication.

In the United States, Onivyde is approved for metastatic pancreatic ductal adenocarcinoma in combination with fluorouracil and leucovorin after progression on gemcitabine therapy. This indication was established by the NAPOLI-1 trial, which showed an improvement in overall survival compared with 5-FU/LV alone.

Onivyde is administered by intravenous infusion as part of a combination regimen with 5-fluorouracil and leucovorin. Dosing and schedule follow the prescribing information. Supportive care, antiemetics, and monitoring for adverse effects are routinely used.

Common adverse effects include neutropenia, diarrhea (early and late), nausea, vomiting, fatigue, and abdominal pain. Severe diarrhea and neutropenia are notable risks, and pharmacogenomic factors such as UGT1A1 variants can influence toxicity.

It is marketed in several regions under the brand Onivyde by Ipsen, with regulatory approvals in the US and Europe for second-line metastatic pancreatic cancer after gemcitabine. Ongoing research explores use in other cancers and combinations.