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CAMBRIDGE, Mass. — The Food and Drug Administration has granted orphan drug designation to a chemotherapy drug made by Merrimack Pharmaceuticals for pancreatic cancer, the drug maker said Monday.
Merrimack announced that it received the designation for MM-398, described as a novel, stable, nanotherapeutic encapsulation of the chemotherapy drug irinotecan.
The FDA gives orphan drug designation to treatments for diseases that affect fewer than 200,000 people in the United States. Once approved, an orphan drug gets extended market exclusivity, regulatory fee reductions and support for research and development initiatives.