On November 19, 2014 Merrimack Pharmaceuticals reported that the U.S. Food and Drug Administration (FDA) has granted MM-398 (nanoliposomal irinotecan injection), also known as ”nal-IRI,” Fast Track designation for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy (Press release Merrimack, NOV 19, 2014, View Source [SID:1234500983]). Fast Track is designed by the FDA to facilitate and expedite the development and review of drugs that treat serious conditions and fill an unmet medical need.

Pancreatic cancer is the fourth leading cause of cancer-related deaths in the United States and is projected to be the second highest cause of death from cancer in the United States by 2020. It is a rare and deadly disease that is difficult to diagnose and has limited treatment options available.

“It is crucial to develop new therapies for patients with pancreatic cancer, particularly for those patients who have previously received gemcitabine-based therapy where there is currently no consensus on the standard of care,” said Eliel Bayever, M.D., Vice President at Merrimack and medical director for MM-398. “We will continue to work diligently on our NDA submission in an effort to bring MM-398 to patients who are facing this aggressive disease as quickly as possible.”

Merrimack is currently preparing a New Drug Application (NDA) for MM-398 in the United States for the treatment of patients with metastatic pancreatic cancer previously treated with a gemcitabine-based therapy. Fast Track designation allows sections of the NDA to be submitted to the FDA as they are completed. Based upon this designation, Merrimack expects to initiate the NDA submission in 2014 with the goal of completing the NDA submission late in the first quarter or early in the second quarter of 2015.

The US FDA and European Medicines Agency have granted MM-398 orphan drug designation in metastatic pancreatic cancer. Merrimack and Baxter International’s biopharmaceutical business (NYSE:BAX) entered into an exclusive licensing agreement to develop and commercialize MM-398 outside of the United States. Baxter expects to submit for regulatory approvals outside of the United States beginning in 2015.