FDA News

FDA grants fast track designation to PEGPH20 program for metastatic pancreatic cancer

The FDA granted fast track designation today to Halozyme Therapeutics for its PEGPH20 program in treating patients with pancreatic cancer, according to a company press release.

The program seeks to demonstrate improved overall survival in metastatic pancreatic cancer patients by studying the use of pegylated recombinant human hyaluronidase in combination with gemcitabine and nab-paclitaxel.

“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,” Helen Torley, MB, ChB, Halozyme president and CEO, said in the release. “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 FDA granted fast track designation today to Halozyme Therapeutics for its PEGPH20 program in treating patients with pancreatic cancer, according to a company press release.

The program seeks to demonstrate improved overall survival in metastatic pancreatic cancer patients by studying the use of pegylated recombinant human hyaluronidase in combination with gemcitabine and nab-paclitaxel.

“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,” Helen Torley, MB, ChB, Halozyme president and CEO, said in the release. “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.”