Baxter and Merrimack apply for EU approval of pancreatic cancer drug

Baxter BioSciences and Merrimack Pharmaceuticals have submitted a marketing authorisation application to the European Medicines Agency for approval of their new drug MM-398.

Also known as nal-IRI, this investigational treatment is intended for patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy.

Both this and the prior US filing were based on positive findings from the phase III NAPOLI-1 study, which showed that the drug provided positive progression-free and overall survival benefits for patients in this group.

This was the first global phase III study in a post-gemcitabine setting to show a survival benefit for this aggressive disease.

David Meek, head of oncology at Baxter BioScience, said: "MM-398 is an important asset in our oncology portfolio that will be investigated for other cancers where there remains unmet medical need."

The Baxter BioScience business will soon be spun off into an independent company called Baxalta, which will be led by Dr Ludwig Hantson.