Onivyde Approved for Pancreatic Cancer
October 22, 2015 – The U.S. Food and Drug Administration approved Onivyde (irinotecan liposome injection) for the treatment of advanced pancreatic cancer for patients who previously received therapy with gemcitabine. Onivyde is manufactured by Merrimack Pharmaceuticals.
Approximately 49,000 patients are diagnosed with pancreatic cancer each year in the U.S. Pancreatic cancer is extremely difficult to diagnose and treat and statistics show that about three-fourths of patients live less than one year after diagnosis, with fewer than 10% surviving for five years or more.
The recommended dosing for Onivyde is 70mg per square meter of body surface area through intravenous (IV) infusion once every two weeks. Onivyde should only be used in combination with fluorouracil (5-FU) and leucovorin. Additionally, patients should also receive an anti-nausea drug and dexamethasone one-half hour before each 90-minute infusion of Onivyde. Dosage forms available are the 10mL single-use vial, each containing 43mg of Onivyde. Pricing information is not yet available for Onivyde but is scheduled to be launched last week of October.
Onivyde is not interchangeable with Camptosar (irinotecan injection, Pfizer) or generic irinotecan products presently in the U.S. market. Boxed warnings include severe neutropenia (low levels of white blood cells that fight infections) and severe diarrhea.
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