FDA Grants Oncolytics’ Pancreatic Cancer Drug Orphan Drug Designation

Today, Oncolytics Biotech Inc. announced that its lead pancreatic cancer drug was granted orphan drug designation by US health regulators.

The company said that its lead product candidate, Reolysin, was granted orphan drug status by the US Food and Drug Administration (FDA) for the treatment of pancreatic cancer. The agency provides orphan drug designation to drugs or biologics being developed for rare diseases, defined as affecting fewer than 200,000 people in the US.

The American Cancer Society (ACS) estimates that 48,960 Americans will be diagnosed with pancreatic cancer and an estimated 40,560 Americans will die from the disease in 2015. In the US, approximately 44,539 patients are affected with pancreatic cancer at any time. The prognosis for individuals diagnosed with the disease is generally poor, regardless of the stage of diagnosis. The relative five-year survival rate for all stages of pancreatic cancer combined is approximately seven percent.

“This is the second indication for which we have received Orphan Drug Designation in the United States,” said Dr. Brad Thompson, President and CEO of Oncolytics. “The prognosis for pancreatic cancer is typically poor, and it is critical to expand the range of treatment options available to these patients.”

The FDA already granted orphan drug designation for the use of Reolysin for the treatment of ovarian cancer.

The drug is Oncolytics’ proprietary isolate of the reovirus. Reolysin’s primary mode of activity is to infect and selectively target tumors with activating Ras pathway mutations and/or over-expressions of Ras pathway elements including, amongst others, EGFR, BRAF and KRAS. Among pancreatic cancers, up to 70 percent have activating Ras pathway mutations and/or over-expressions.

Source: Oncolytics Biotech Inc.

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