The Food and Drug Administration (FDA) has approved Onivyde (irinotecan liposome injection; Merrimack) as part of a combination regimen with fluorouracil (5-FU) and leucovorin for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.

The approval of Onivyde was based on data from a large, international, randomized clinical trial, NAPOLI-1 (NAnoliPOsomaL Irinotecan) that enrolled 417 patients at more than 100 sites in North America, South America, Europe, Asia, and Australia. Study patients all had metastatic pancreatic cancer that was previously treated with the traditional standard-of-care, gemcitabine-based therapy. Results from the study showed significant overall survival rates with Onivyde compared to the other tested treatments. Therapy with Onivyde resulted in a patient survival rate of nearly 2 more months without decreasing the quality of life. 

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Onivyde is a topoisomerase 1 inhibitor encapsulated in a lipid bilayer vesicle, or liposome. Irinotecan and its active metabolite bind reversibly to the topoisomerase 1-DNA complex and prevent re-ligation of the single-strand breaks, leading to exposure time-dependent double-strand DNA damage and cell death.

Onivyde injection is available as 43mg/10mL single-dose vials.

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