First-in-Class Pancreatic Cancer Drug Gains Orphan Drug Status

FibroGen announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation to pamrevlumab for the treatment of pancreatic cancer.

Pamrevlumab is a first-in-class antibody designed to inhibit the connective tissue growth factor (CTGF). In pancreatic cancer, CTGF in the extensive fibrous stroma associated with tumors promotes abnormal proliferation of stromal cells and tumor cells.

Clinical trials of pamrevlumab are currently ongoing for conditions such as idiopathic pulmonary fibrosis, pancreatic cancer, and Duchenne muscular dystrophy (DMD). Favorable data has emerged from Phase 2 trials in patients with advanced pancreatic cancer in terms of median and 1-year survival. 

“An ongoing study in locally advanced non-resectable pancreatic cancer has shown promise in converting pancreatic cancer from non-resectable to surgically viable,” said Tom Neff, CEO of FibroGen. The open-label trial is comparing pamrevlumab in combination with chemotherapy standard-of-care vs. chemotherapy alone. 

For more information visit FibroGen.com.