On March 1, 2018 FibroGen, Inc. (NASDAQ:FGEN), a science-based biopharmaceutical company, reported 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 (Press release, FibroGen, MAR 1, 2018, View Source;p=RssLanding&cat=news&id=2335711 [SID1234524303]).
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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."
About Fast Track Designation
Fast Track designation is intended to facilitate the development and review of drugs used to treat serious conditions and to fill an unmet medical need. Fast Track designation enables the company to have more frequent interactions with the FDA throughout the drug development process, so that an approved product can reach the market expeditiously.
About Locally Advanced Pancreatic Cancer
In locally advanced pancreatic cancer (LAPC), the patient’s tumor typically involves structures, particularly blood vessels that are closely associated with the pancreas such as the superior mesenteric artery and superior mesenteric vein. Involvement of the cancer around these blood vessels precludes surgical removal of the tumor. Patients with unresectable LAPC have a median survival of six to 10 months, only slightly better than patients with metastatic pancreatic cancer, and only 20 percent of newly diagnosed patients are classified as having resectable disease. Patients who have their tumor surgically removed have a much better prognosis with median survival of approximately 23 months with some patients being cured.
About Pamrevlumab
Pamrevlumab is a first-in-class antibody developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders. Fibrosis is characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. In desmoplastic, or fibrotic cancers, such as pancreatic cancer, fibrous tissue promotes abnormal proliferation of tumor cells and associated stromal cells. Pamrevlumab is advancing towards Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and pancreatic cancer, and is currently in a Phase 2 trial for Duchenne muscular dystrophy (DMD). In Phase 2 clinical studies conducted to date, pamrevlumab has demonstrated a good safety and tolerability profile. For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.