FDA grants orphan drug designation to Reolysin for malignant gliomas

The FDA today granted orphan drug designation to pelareorep for the treatment of patients with malignant gliomas, according to a press release from the drug’s manufacturer.

The FDA based its decision in part on results of three brain cancer studies of pelareorep (Reolysin, Oncolytics Biotech) in gliomas. Study results demonstrated that pelareorep infected a variety of brain tumors when administered intravenously.

Oncolytics Biotech applied for an orphan drug designation for pelareorep for pediatric high grade gliomas; however, the FDA granted the designation for the broader indication of pelareorep for all patients with malignant glioma.

"The focus of our Orphan Drug submissions has been on difficult to treat cancers where patients have few effective treatment options," Brad Thompson, PhD, president and chief executive officer of Oncolytics Biotech, said in a press release. "Pediatric patients with high grade gliomas have particularly poor expected outcomes. We believe these patients, along with the adult population affected by malignant gliomas, would benefit from having additional treatment options."

Pelareorep has recently received orphan drug designation for a variety of other cancers, including pancreatic and ovarian cancers.

The FDA’s 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.