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FDA Grants Orphan Drug Designation to Investigational Agent for Pancreatic Cancer

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The U.S. Food and Drug Administration (FDA) has 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 gemcitabine and albumin-bound paclitaxel (nab-paclitaxel [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.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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