UPDATE: FDA accepts Merrimack’s MM-398 NDA for speedy review

The New Drug Application for MM-398 (irinotecan liposome injection), also known as "nal-IRI," has been accepted for review by the US Food and Drug Administration (FDA), according to the NDA’s sponsor, Merrimack Pharmaceuticals (Nasdaq: MACK), whose shares rose 6,4% to $12,64 on the news.

Merrimack is seeking US marketing approval of MM-398 for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy. The drug is licensed to Baxalta, a wholly-owned subsidiary of Baxter International (NYSE: BAX), outside the USA and Taiwan (The Pharma Letter September 24, 2014).

Drug gets priority review status