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FDA Grants Orphan Drug Designation to Reolysin for Gastric Cancer
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The FDA granted orphan drug designation to pelareorep for the treatment of gastric cancer, the drug’s manufacturer announced today.
In addition to the receipt of orphan drug designation for the treatment of malignant gliomas in April, pelareorep (Reolysin, Oncolytics Biotech) has recently received orphan drug designations for pancreatic, peritoneal, ovarian, and fallopian tube cancers.
"Oncolytics has assembled a portfolio of six indications where we have been granted Orphan Drug Designation by the FDA," Brad Thompson, PhD, president and CEO of Oncolytics Biotech, said in a press release "We expect this will provide us with greater flexibility in the future development of Reolysin for these difficult to treat cancers."
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.
Disclosure: Thompson is an employee of Oncolytics Biotech.