FDA Approves Onivyde for Advanced Pancreatic Cancer

The US Food and Drug Administration (FDA) today approved Onivyde (irinotecan liposome) to treat pancreatic cancer that has spread (metastasized) to other parts of the body. It’s for people who have previously been treated with the chemotherapy drug Gemzar (gemcitabine) and is to be given in combination with two other chemotherapy drugs – fluorouracil and leucovorin.

Pancreatic cancer often does not cause signs or symptoms in the early stages, and therefore is often not found until it has already spread. Treatment options for advanced pancreatic cancer are often limited. But the new combination of drugs has shown to help patients live longer.

Onivyde received priority review status, under which the FDA tries to make a decision within 6 months instead of the usual 10 months, and it received orphan drug designation, which encourages the development of drugs for rare diseases.

The FDA based today’s approval on a study of 417 people with metastatic pancreatic cancer whose cancer grew after they received gemcitabine. Those who received the Onivyde-fluorouracil-leucovorin combination lived an average 6.1 months, compared to 4.2 months for those who received fluorouracil and leucovorin only. People who received the Onivyde-fluorouracil-leucovorin combination also had a longer time (3.1 months) before their tumors began growing than those who received fluorouracil and leucovorin only (1.5 months).

Onivyde is given as an infusion into a vein. The most common side effects are diarrhea, fatigue, nausea and vomiting, decreased appetite, inflammation in the mouth, and fever. Onivyde can also cause low counts of infection-fighting cells (lymphopenia and neutropenia), which if severe enough can be life threatening.

The drug carries a boxed warning, which is the FDA’s strongest warning for drugs that have serious side effects. The warning is to alert health care professionals about the risks of severe neutropenia and diarrhea.

Onivyde is marketed by Merrimack Pharmaceuticals Inc.

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