The program is being developed to treat metastatic prostate cancer.
Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Halozyme's program investigating PEGPH20 (PEGylated recombinant human hyaluronidase) in combination with gemcitabine and nab-paclitaxel for the treatment of patients with metastatic pancreatic cancer to demonstrate an improvement in overall survival. 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.
"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 Dr. Helen Torley, President and Chief Executive Officer. "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."
Read the press release: http://bit.ly/YbciJE
Source: Halozyme Therapeutics