Cancer drug marches toward filing
Merrimack Pharmaceuticals said today that its candidate for metastatic pancreatic cancer, MM-398, in combination with 5-FU and leucovorin, met its primary endpoint and will be submitted to the FDA in 2014. The agency granted MM-398 an orphan drug designation for metastatic pancreatic cancer in 2011.
MM-398+5-FU+leucovorin saw an overall survival of 6.1 months, representing a 1.9-month improvement over the 4.2 months of survival demonstrated by a control arm of 5-FU+leucovorin alone. MM-398, on its own, did not demonstrate a statistically significant survival advantage, though.