FDA to Review NDA for Metastatic Pancreatic Adenocarcinoma Therapy
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.
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.
For more information visit MerimackPharma.com.