The injected drug Onivyde (irinotecan liposome) has been approved by the U.S. Food and Drug Administration for pancreatic cancer that has either spread or is surgically untreatable.
Pancreatic cancer is difficult to treat, the agency said, citing U.S. Government estimates that 48,960 new cases would be diagnosed this year and 40,560 would die from it.
The new drug’s effectiveness was evaluated in clinical studies involving 417 people with advanced pancreatic cancer. People treated with a combination of Onivyde and the anti-cancer drugs fluorouracil or leucovorin lived an average of 6.1 months, compared to 4.2 months among those treated with fluorouracil or leucovorin alone, the FDA said.
Onivyde’s most common side effects include diarrhea, fatigue, vomiting, loss of appetite, mouth inflammation and fever. The drug’s label also warns that it may cause severe diarrhea and a drop in cells designed to fight infections, the agency said.
Onivyde is marketed by Merrimack Pharmaceuticals, based in Cambridge, Mass.
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