Reolysin filed for Gastric Cancer orphan status

Oncolytics Biotech Inc. announced the submission of an application to the FDA seeking orphan drug designation for its lead pipeline candidate, Reolysin, for the treatment of gastric cancer. Reolysin already enjoys orphan drug status for primary peritoneal, fallopian tube, ovarian and pancreatic cancer in the U.S. and for primary peritoneal, fallopian tube and ovarian cancer in the EU.

The FDA usually grants orphan drug status to drugs or biologics that are being developed for the treatment of rare diseases/conditions affecting less than 200,000 people in the U.S. at any given time. This designation allows the product to enjoy a period of marketing exclusivity in the U.S., upon approval. Incentives that come with orphan drug status include tax credits as well as waiver of certain administrative fees.

According to the American Cancer Society, approximately 24,590 people in the U.S. are estimated to be diagnosed with gastric cancer this year with 10,720 people expected to die from the disease.