Aduro Biotech Receives Orphan Drug Designation for CRS-207 for Pancreatic Cancer
BERKELEY, Calif.--(BUSINESS WIRE)--Aduro BioTech, Inc. announced today that the Office of Orphan Products Development of the Food and Drug Administration (FDA) has granted orphan drug designation for CRS-207, a novel immunotherapy, for the treatment of pancreatic cancer. The FDA had previously granted the same designation for the company’s GVAX Pancreas, another cancer immunotherapy that is being evaluated in combination with CRS-207. Orphan designation qualifies Aduro for seven years of marketing exclusivity in the U.S. if the company is the first to obtain marketing approval for the immunotherapies in pancreatic cancer and also qualifies the company for certain tax credits and waivers for prescription drug user fees.
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