FDA approves Merrimack’s metastatic pancreatic cancer drug

Onivyde, in combination with chemotherapy drugs fluorouracil (5-FU) and leucovorin has been approved for treatment of metastatic pancreatic cancer patients who have undergone gemcitabine-based chemotherapy.

The drug’s effectiveness in extending lives was evaluated in a clinical study involving 417 patients whose tumors had increased after receiving a chemotherapy.

Patients treated with Onivyde and fluorouracil/leucovorin lived an average of 6.1 months compared to 4.2 months for those treated only with fluorouracil/leucovorin.

FDA approved the drug with a boxed warning, alerting health care professionals on the risks of side effects including severe neutropenia and diarrhea.

Onivyde was approved to be used only in combination with chemotherapy, not as a single agent. It was granted priority review and orphan drug designations by the FDA.

FDA’s Center for Drug Evaluation and Research director of the Office of Hematology and Oncology Products Richard Pazdur said: "By using the Priority Review designation for the application for Onivyde, patients will have earlier access to a drug that helps extend survival."

Merrimack president and CEO Robert Mulroy said: "Pancreatic cancer is an aggressive and devastating disease, with very few patients surviving beyond one year.

"Onivyde provides a clinically significant treatment option to a patient population where there is currently no standard of care."

Merrimack plans to launch Onivyde in the US shortly. PharmaEngine holds the rights to commercialize the drug in Taiwan.

Image: Merrimack’s Onivyde drug is aimed at treating metastatic pancreatic cancer patients who have undergone gemcitabine-based chemotherapy. Photo: courtesy of dream designs/FreeDigitalPhotos.net.