Onivyde gets U.S., Taiwan approval
FDA and Taiwan FDA both approved Onivyde irinotecan ( MM-398) in combination with 5-fluorouracil (5-FU) and leucovorin to treat metastatic pancreatic cancer in patients previously treated with gemcitabine-based chemotherapy. Merrimack Pharmaceuticals Inc. (NASDAQ:MACK) holds U.S. rights to the drug from PharmaEngine Inc. (TPEx:4162), which retains Taiwanese rights.
Merrimack intends to launch Onivyde next week at a wholesale acquisition cost of $11,200 per month, or about $43,000 per course based on a mean treatment duration of 3.8 months in the Phase III NAPOLI-1 study. The drug's label includes a boxed warning about risks of severe neutropenia and diarrhea. The nanoparticle liposome formulation of irinotecan targets topoisomerase I ( TOP1). ...