Onivyde 安能得 irinotecan liposome

Drug Class

Topoisomerase inhibitor liposome

Mechanism

Irinotecan liposome is a formulation of irinotecan encapsulated in liposomes, which converts to its active metabolite SN-38 to inhibit topoisomerase I, leading to double-strand DNA damage and cell death.

Approved Indication

Treatment of metastatic pancreatic adenocarcinoma in combination with oxaliplatin, fluorouracil, and leucovorin as first-line therapy; or in combination with fluorouracil and leucovorin after disease progression following gemcitabine-based therapy.

What This Means For Patients

Onivyde (irinotecan liposome injection) is an encapsulated formulation of chemotherapy used to treat advanced pancreatic cancer. The liposomal design helps deliver the drug more selectively into tumors and prolong circulation time. It is approved in mainland China and also accessible in the Boao Lecheng pilot zone.

Regulatory Approvals

• FDA — approved (2015) — label
• EMA — approved (2016) — source
• NMPA — approved (2022) — source

Pivotal Clinical Evidence

• NAPOLI-3 — Wainberg et al., Lancet 2023 (NCT04083235) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207793s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/onivyde
• https://doi.org/10.1016/S0140-6736(23)01366-1