Merrimack Pharmaceuticals Inc (NASDAQ:MACK) has announced today that the Foods and Drugs Administration (FDA) has approved today the use of Onivyde, a drug designed to treat patients with metastatic pancreatic cancer who previously have been treated with gemcitabine-based chemotherapy. Onivyde is approved to administrated in combination with fluorouracil and leucovorin.
The decision of the FDA is based upon a 3-arm randomized, open label study with 417 patients enrolled. Results from the study have revealed that Onivyde treatment can extend life of patients with advanced pancreatic cancer. The study showed that the drug Onivyde in combination with fluorouracil and leucovorin achieved the primary endpoint of the trial with a significant improvement in overall survival, equivalent to a 45 per cent improvement in median overall survival of 6.1 months, which was witnessed in patients on the Onivyde in combination therapy. Without combination a median overall survival 4.2 month was witnessed in patients.
Robert Mulroy, president and CEO of Merrimack, said in a statement, "We are thrilled to be able to deliver this groundbreaking therapy to patients battling metastatic pancreatic cancer,"
The FDA did initiate a severe waning regarding the use if the drug. The warning flags severe risks of diarrhea and low white blood cell count.