Irinotecan regulatory update

Merrimack completed submission of a rolling NDA to FDA for MM-398 to treat metastatic adenocarcinoma of the pancreas in patients who have been previously treated with gemcitabine-based therapy. The company requested Priority Review for the application. The nanoparticle liposome formulation of irinotecan has Fast Track designation in the U.S. and Orphan Drug designation in the U.S. and EU for pancreatic cancer. ...