Aduro Biotech, Inc. today announced that the Office of Orphan Product Development of the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to CRS-207, a novel immuno-oncology product candidate, for the treatment of mesothelioma. This designation potentially allows Aduro seven years of limited marketing exclusivity in the United States if it is the first to obtain FDA marketing approval for mesothelioma, and qualifies the company for grant funding to offset the cost of clinical testing as well as tax credits for certain research and a waiver of the Biologics License Application user fee. The FDA previously granted orphan designation to CRS-207 and GVAX Pancreas for the treatment of pancreatic cancer.
“This is an important step for Aduro as we continue to develop CRS-207 for this very difficult to treat cancer,” said Dirk Brockstedt, Ph.D., senior vice president of research and development at Aduro. “We believe the combination of CRS-207 together with chemotherapy may offer the promise of a potential new therapeutic regimen for patients suffering from mesothelioma. Importantly, we plan to report additional data from the ongoing Phase 1b study later this year.”
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