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# Rainier Therapeutics Fast Track for Bladder Cancer Therapy
- URL: https://www.fdaweb.com/rainier-therapeutics-fast-track-for-bladder-cancer-therapy/
- Published: 2019-01-07T12:00:00.000Z
- Updated: 2026-09-15T00:52:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143099

FDA has granted Rainier Therapeutics a fast track designation for its targeted antibody vofatamab for treating patients with advanced or metastatic urothelial cell carcinoma (bladder cancer) that is positive for FGFR3 mutation 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, according to the company. Rainier has ongoing Phase 1b and Phase 2 clinical studies of vofatamab in metastatic bladder cancer – the Fierce 21 and Fierce 22 studies. In addition, it plans to study vofatamab in early stage bladder cancer, the Fierce 23 trial.