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 安能得 is not distributed through mainland China's retail pharmacy network. Uwell Cloud can help arrange a purchase channel for this medicine, sourced and dispatched from Hong Kong; clinical administration support in China can be coordinated on request. Availability and eligibility for any specific patient are determined by clinical review.

Regulatory Approvals

• FDA — Approved (2015) — Sources
• EMA — Approved (2016) — Sources
• NMPA — Approved (2022) — Sources

Pivotal Clinical Evidence

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

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