Halozyme Metastatic Pancreatic Cancer Program Receives Fast Track Designation

Trial is investigating PEGPH20 in combination with gemcitabine and nab-paclitaxel for the treatment of stage IV metastatic pancreatic cancer.

Trial is investigating PEGPH20 in combination with gemcitabine and nab-paclitaxel for the treatment of stage IV metastatic pancreatic cancer.

Halozyme Therapeutics, Inc, announced that the FDA has given fast track designation to its program investigating PEGPH20 as part of a combination treatment for patients with metastatic pancreatic cancer.

The PEGPH20 program involves PEGylated recombinant human hyaluronidase, used in combination with gemcitabine and nab-paclitaxel. The company initiated a phase 2 multicenter clinical trial evaluating PEGPH20 as first-line therapy for patients with stage IV metastatic pancreatic cancer. The study involves 124 participants, who will receive gemcitabine and nab-paclitaxel with or without PEGPH20. The primary outcome will measure progression-free survival between patients administered PEGPH20 and those who did not receive the drug, the company’s website states.

The fast track program facilitates frequent interactions with the FDA review team, in order to expedite clinical development and submission of Biologic License Application for medicines with the potential to treat serious or life-threatening conditions and address unmet medical needs, a company press release notes.

“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,” Dr. Helen Torley, president and chief executive officer, said in a press 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.”