Posted by Michael Wonder on 01 Mar 2018
FibroGen granted fast track designation by U.S. FDA for pamrevlumab treatment of patients with locally advanced unresectable pancreatic cancer
1 March 2018 - FibroGen today announced that the U.S. 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.
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. In Phase 2 clinical studies conducted to date, pamrevlumab has demonstrated a good safety and tolerability profile.
