October 03, 2014
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FDA grants orphan drug designation to PEGPH20 for pancreatic cancer

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The FDA has granted orphan drug designation to pegylated recombinant human hyaluronidase for the treatment of pancreatic cancer, according to a press release.

Pegylated recombinant human hyaluronidase (PEGPH20, Halozyme Therapeutics) is an investigational drug being developed for the systemic treatment of hyaluronan-accumulating tumors, the release said.

“This designation follows the fast track designation and allows us to collaborate more closely with the FDA to facilitate development of PEGPH20 and is part of our core strategy to bring this therapy to patients as rapidly as possible,” Helen Torley, MB, ChB, president and CEO of Halozyme, said in the release. “Receiving orphan drug designation is an important milestone for this clinical development program.”

A phase 2 study of PEGPH20 in combination with gemcitabine (Gemzar, Eli Lilly) and nab-paclitaxel (Abraxane, Celgene) for metastatic pancreatic cancer treatment is currently under way, the release said.