FDA Grants Fast Tract Designation to Investigational Combination Therapy In Metastatic Pancreatic Cancer

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The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Halozyme Therapeutics’ program investigating pegylated recombinant human hyaluronidase (PEGPH20) in combination with gemcitabine and albumin-bound paclitaxel (nab-paclitaxel [Abraxane]) for the treatment of patients with metastatic pancreatic cancer to demonstrate an improvement in overall survival.

“The FDA’s Fast Track designation for our PEGPH20 program in pancreatic cancer underscores the significant need for new treatment options for pancreatic cancer patients with advanced disease,” stated Helen Torley, MD, President and Chief Executive Officer of Halozyme. “We look forward to continuing to work with the FDA on this program to explore whether patients with metastatic pancreatic cancer can benefit from this therapy.”

The Fast Track designation process was developed by the FDA to facilitate the development, and expedite the review of drugs to treat serious or life-threatening diseases and address unmet medical needs. ■




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