Merrimack Pharmaceuticals and Baxalta announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for irinotecan liposome injection (MM-398) for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy.

The NDA submission is based upon the results of an international Phase 3 NAPOLI-1 study conducted in patients with metastatic pancreatic cancer who previously received gemcitabine-based therapy. MM-398 in combination with 5-fluorouracil (5-FU) and leucovorin achieved its primary and secondary endpoints by demonstrating a statistically significant improvement in overall survival, progression free survival and overall response rate compared to the control group of patients who received a combination of 5-FU and leucovorin.

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The FDA has granted MM-398 Orphan Drug designation for patients with metastatic pancreatic cancer. MM-398 was granted Fast Track designation by the FDA in November 2014.

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