|FDA's Dr. Richard Pazdur|
Cambridge, MA-based Merrimack Pharmaceuticals has won FDA approval to market Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, for patients with metastatic pancreatic cancer.
The approval comes after investigators nailed down late-stage data demonstrating a 1.9-month survival advantage over patients taking only fluorouracil/leucovorin. The drug arm in the study also demonstrated a progression-free survival advantage that was slightly more than double the 1.5 months recorded in the control group.
Merrimack's big idea here was to take the chemo drug irinotecan and wrap it in a nanoliposomal capsule to provide extended circulation in patients, amping up its effect on cancer.
The drug earlier failed to provide a statistically significant difference as a monotherapy, which will likely add this drug to the list of therapies with only a marginal advantage for advanced patients. But with new pancreatic cancer therapies few and far between, doctors are also likely eager to add it to their list of last-ditch therapeutic strategies.
"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."
- here's the release