Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Halozyme Therapeutics has received fast track designation from the US Food and Drug Administration (FDA) for its program investigating PEGPH20 in combination with gemcitabine and nab-paclitaxel to treat patients with metastatic pancreatic cancer.
Subscribe to our email newsletter
In the program, the company will investigate PEGPH20 (PEGylated recombinant human hyaluronidase) to show improvement in overall survival (OS).
The FDA fast track status will help in the development and expedite the review of drugs to treat serious or life-threatening diseases and address unmet medical needs.
Halozyme president and chief executive officer Dr Helen Torley said the FDA’s fast track designation for its PEGPH20 program in pancreatic cancer underscores the significant need for new treatment options for pancreatic cancer patients with advanced disease.
"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," Torley said.
The company’s research focuses primarily on a family of human enzymes called as hyaluronidases, which increase the dispersion and absorption of biologics, drugs and fluids.