Halozyme Therapeutics, Inc.
HALO today announced that the U.S. Food and Drug Administration
(FDA) has granted Fast Track designation for Halozyme's program
investigating PEGPH20 (PEGylated recombinant human hyaluronidase) in
combination with gemcitabine and nab-paclitaxel for the treatment of
patients with metastatic pancreatic cancer to demonstrate an improvement in
overall survival. The Fast Track designation process was developed by the
FDA to facilitate the development, and expedite the review of drugs to treat
serious or life-threatening diseases and address unmet medical needs.
"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," stated Dr. Helen Torley,
President and Chief Executive Officer. "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 Fast Track Drug Development Program was established under the FDA
Modernization Act of 1997. The program is designed to facilitate frequent
interactions with the FDA review team to expedite clinical development and
submission of a Biologic License Application (BLA) for medicines with the
potential to treat serious or life-threatening conditions and address unmet
medical needs. Specifically, Fast Track designation facilitates meetings to
discuss all aspects of development to support approval. It also provides the
opportunity to submit sections of a BLA on a rolling basis as data become
available. This permits the FDA to review portions of the BLA as they are
received instead of waiting for the entire BLA submission.
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