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FDA grants orphan drug designation to Reolysin for pancreatic cancer
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The FDA granted orphan drug status to pelareorep for the treatment of pancreatic cancer, the drug’s manufacturer announced today.
Pelareorep (Reolysin, Oncolytics Biotech) is designed to infect and selectively target tumors with activating RAS pathway mutations and/or overexpression of RAS pathway elements, including — but not limited to — EGFR, BRAF and KRAS.
“This is the second indication for which we have received orphan drug designation in the United States,” Brad Thompson, PhD, president and CEO of Oncolytics Biotech, said in a press release. “The prognosis for pancreatic cancer is typically poor, and it is critical to expand the range of treatment options available to these patients.”
Last week, Oncolytics Biotech announced that pelareorep received orphan drug designation for the treatment of ovarian cancer.
The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States.