Halozyme Therapeutics Inc. today announced that the Food and Drug Administration has granted Fast Track designation for its program investigating a treatment for patients with metastatic pancreatic cancer.
Halozyme’s (Nasdaq: HALO) drug candidate, PEGPH20 in combination with gemcitabine and nab-paclitaxel, is intended 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,” said Helen Torley, president and CEO 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 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.