Wednesday, March 07, 2018 9:13:35 AM
SAN FRANCISCO, March 01, 2018 (GLOBE NEWSWIRE) -- FibroGen, Inc. (FGEN), a science-based biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the company’s anti-CTGF antibody, pamrevlumab, for the treatment of patients with locally advanced unresectable pancreatic cancer. This follows review of the Phase 2 clinical trial evaluating pamrevlumab in combination with gemcitabine and nab-paclitaxel and represents recognition by the FDA that pamrevlumab has the potential to address an unmet medical need for this disease.
“There are no approved treatment options for patients with locally advanced pancreatic cancer, who face a short life expectancy. We are encouraged by our Phase 2 study results, where the combination of pamrevlumab with chemotherapy changed eligibility for surgical resection in a majority of treated patients who were previously not candidates for surgery,” said Peony Yu, M.D., FibroGen’s Chief Medical Officer. “This designation is an important milestone for our pamrevlumab program and has the potential to speed our ability to advance pamrevlumab to patients.”
https://finance.yahoo.com/news/fibrogen-granted-fast-track-designation-184522812.html
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