FDA approves Merrimack's Onivyde as pancreatic cancer treatment

PharmaEngine Inc. recently announced the U.S. Food and Drug Administration's (FDA) approval of Merimack's Onivyde (irinotecan liposome injection) in combination with fluorouracil (5-FU) and leucovorin (LV).

Onivyde is indicated for the treatment of metastatic adenocarcinoma of the pancreas after unsuccessful gemcitabine-based therapy. It has also been approved in Taiwan.

"Onivyde is the first cancer drug to begin its clinical development in Taiwan and go on to receive regulatory approval by the U.S. FDA," PharmaEngine CEO and President C. Grace Yeh said. "We applaud Merrimack for achieving this important milestone and we are pleased to have supported Merrimack in completing the final phase of the development for this new drug application."

The most common serious adverse reactions of Onivyde were diarrhea, vomiting, neutropenic fever or neutropenic sepsis, nausea, pyrexia, sepsis, dehydration, septic shock, pneumonia, acute renal failure and thrombocytopenia.

Further information is available at www.pharmaengine.com.