On September 3, 2014 Halozyme Therapeutics reported 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 (Press release Halozyme, SEP 3, 2014, View Source [SID:1234500722]). 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.”

The Fast Track Drug Development Program was established under the FDA Modernization Act of 1997. The program is designed to facilitate frequent interactions with the FDA review team to expedite clinical development and submission of a Biologic License Application (BLA) for medicines with the potential to treat serious or life-threatening conditions and address unmet medical needs. Specifically, Fast Track designation facilitates meetings to discuss all aspects of development to support approval. It also provides the opportunity to submit sections of a BLA on a rolling basis as data become available. This permits the FDA to review portions of the BLA as they are received instead of waiting for the entire BLA submission.