Posted by Michael Wonder on 07 Jan 2019
Rainier Therapeutics announces fast track designation granted by FDA for vofatamab in treatment of FGFR3-positive urothelial cell carcinoma
7 January 2019 - Rainier Therapeutics today announced that its targeted antibody vofatamab has received fast track designation from the U.S. FDA for treatment of patients with advanced or metastatic urothelial cell carcinoma that is positive for FGFR3 mutation and/or fusion.
Vofatamab (B-701) is an antibody specifically targeted against the fibroblast growth factor receptor 3 (FGFR3), a known driver of bladder and other cancers. Vofatamab is the most advanced targeted biologic specific for FGFR3 known by Rainier to be in clinical development.
Rainier Therapeutics has ongoing Phase 1b and Phase 2 clinical studies of vofatamab in metastatic bladder cancer – the Fierce 21 and Fierce 22 studies. In addition, Rainier Therapeutics plans to study vofatamab in early stage bladder cancer – the Fierce 23 trial.
