First-in-Class Pancreatic Cancer Candidate Gets Fast Track Status

FibroGen announced that the Food and Drug Administration (FDA) has granted Fast Track designation for pamrevlumab for the treatment of patients with locally advanced unresectable pancreatic cancer. 

Pamrevlumab is a first-in-class anti-connective tissue growth factor (CTGF) antibody. CTGF is a common mediator in fibrotic and proliferative disorders. In fibrotic cancers, such as pancreatic cancer, fibrous tissue promotes abnormal spread of tumor cells and associated stromal cells. 

The Fast Track designation was supported by data from a Phase 2 study evaluating pamrevlumab in combination with gemcitabine and nab-paclitaxel. A Phase 2 open-label study also showed pamrevlumab in combination with gemcitabine and erlotinib led to a dose-dependent improvement in 1-year survival rate. 

“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.

Pamrevlumab is also being investigated in the treatment of idiopathic pulmonary fibrosis (IPF) and Duchenne muscular dystrophy.

For more information visit FibroGen.com.