FDA Grants Orphan Drug Designation to Investigational Agent for Pancreatic Cancer
Pancreatic cancer is one of the deadliest forms of cancer. Each year, approximately 43,000 people are diagnosed with pancreatic cancer in the United States and close to 37,000 die from the disease. The disease is often diagnosed at an advanced stage, and treatment of advanced disease remains challenging. The current standard of care consists of chemotherapy drug regimens and a recent clinical study has demonstrated improved outcomes with the combination of Abraxane® (nab-paclitaxel) plus Gemzar® (gemcitabine).1
The U.S. Food and Drug Administration (FDA) has now granted Orphan Drug Designation to pegylated recombinant human hyaluronidase (PEGPH20) for the treatment of pancreatic cancer. Halozyme Therapeutics is currently investigating PEGPH20 in a phase II study in combination with Gemzar and Abraxane.
The FDA’s Orphan Drug program provides orphan status to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the United States. This designation provides eligibility for a 7-year period of market exclusivity in the United States after product approval, FDA assistance in clinical trial design, and an exemption from FDA user fees.
1. Von Hoff DD, Ervin T, Arena FP, et al. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. New England Journal of Medicine. 2013; 369(18): 1691-703
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