The European Commission has granted orphan drug designation to pegylated recombinant human hyaluronidase, or PEGPH20, for treatment of pancreatic cancer, the manufacturer announced.
PEGPH20 (Halozyme) is an investigational pegylated form of recombinant human hyaluronidase which is being developed for the systemic treatment of tumors that accumulate hyaluronan, the release said. The designation follows the recommendation of the European Medicines Agency and orphan drug designation by the FDA in October 2014.
“We are very pleased that PEGPH20 has received orphan drug status in the EU,” Helen Torley, president and CEO of Halozyme, said in the release. “This designation is an important regulatory milestone for Halozyme and aligns with our commitment to deliver innovative therapies that transform the lives of cancer patients around the world.”
A phase 2 study of PEGPH20 in combination with gemcitabine and nab-paclitaxel (Abraxane, Celgene) for treatment of metastatic pancreatic cancer is currently underway, according to the release.