This article is more than 5 years old. Information may no longer be current.

FDA grants orphan drug designation to Reolysin for pancreatic cancer

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

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.