SILVER SPRING, Md. — The Food and Drug Administrtion on Thursday announced that it had approved Merrimack Pharmaceuticals’ Onivyde (irinotecan liposome) injection. The drug is a treatment for metastatic pancreatic cancer in combination with fluoracil and leucovorin.
“Many FDA staff who review drug applications are clinicians as well, so it’s especially rewarding when we are able to expedite access to new treatments for patients with unmet needs,” said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “By using the Priority Review designation for the application for Onivyde, patients will have earlier access to a drug that helps extend survival.”
Onivyde includes a boxed warning about potential risks of sever neutropenia and diarrhea among patients being treated with it.