Irinotecan liposome (Onivyde)
Class/mechanism: Topoisomerase I inhibitor with irinotecan contained within a liposomal sphere. Irinotecan interferes with topoisomerase I's normal action of relieving torsional strain in DNA by creating reversible single-strand breaks. Irinotecan and its active metabolite SN-38 bind to the topoisomerase I & DNA complex and interfere with ligation of these single-strand breaks. Failure to repair these breaks eventually leads to double-strand DNA damage, which disrupts cell proliferation and leads to cell death. In mouse models, 5 times lower doses of liposomal irinotecan were able to achieve similar intratumoral exposure levels of SN-38 as compared to irinotecan HCl.
Extravasation: no information available
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Diseases for which it is used
Patient drug information
History of changes in FDA indication
- 2015-10-22: FDA approved in combination with fluorouracil (5FU) and leucovorin (LV), for the treatment of patients with metastatic adenocarcinoma of the pancreas whose disease has progressed following gemcitabine-based therapy. (Based on NAPOLI-1)
History of changes in EMA indication
- 2016-10-14: Initial authorization
History of changes in Health Canada indication
- 2017-08-09: Initial notice of compliance (unclear details)
History of changes in PMDA indication
- 2020-03-25: Newly indicated for the treatment of unresectable pancreatic cancer that has progressed after cancer chemotherapy.
Also known as
- Code names: MM-398, PEP-02
- Brand name: Onivyde, Onivyde pegylated liposomal