FDA News

FDA grants fast track designation to vofatamab for bladder cancer subset

The FDA granted fast track designation to vofatamab for the treatment of advanced or metastatic urothelial cell carcinoma that harbors fibroblast growth factor receptor 3 mutation or fusion.

Vofatamab (B-701, Rainier Therapeutics) is an antibody that targets fibroblast growth factor receptor 3 (FGFR3), an established driver of bladder cancer and other malignancies.

“This fast track designation underscores the great unmet medical need that exists for the treatment of bladder cancer,” Scott Myers, chairman and CEO of Rainier Therapeutics, said in a company-issued press release. “As the only antibody specifically targeted to FGFR3 we know to be in clinical development, we believe vofatamab offers a promising therapeutic option. We look forward to further data from our ongoing trials and working to advance our development efforts.”

Two trials are underway to evaluate vofatamab for treatment of metastatic bladder cancer.

Fierce 21 is designed to compare vofatamab alone or in combination with docetaxel versus docetaxel alone for patients with locally advanced or metastatic disease with FGFR3 mutations or fusions who relapsed after or were refractory to least one prior line of chemotherapy.

Fierce 22 is designed to evaluate vofatamab in combination with the anti-PD-1 therapy pembrolizumab (Keytruda, Merck) for patients with locally advanced or metastatic disease who progressed after platinum-based chemotherapy but have not received prior immune checkpoint inhibitor therapy.

Another trial — Fierce 23 — is planned to evaluate vofatamab monotherapy for patients with nonmuscle-invasive bladder cancer. That trial is expected to start later this year.


The FDA granted fast track designation to vofatamab for the treatment of advanced or metastatic urothelial cell carcinoma that harbors fibroblast growth factor receptor 3 mutation or fusion.

Vofatamab (B-701, Rainier Therapeutics) is an antibody that targets fibroblast growth factor receptor 3 (FGFR3), an established driver of bladder cancer and other malignancies.

“This fast track designation underscores the great unmet medical need that exists for the treatment of bladder cancer,” Scott Myers, chairman and CEO of Rainier Therapeutics, said in a company-issued press release. “As the only antibody specifically targeted to FGFR3 we know to be in clinical development, we believe vofatamab offers a promising therapeutic option. We look forward to further data from our ongoing trials and working to advance our development efforts.”

Two trials are underway to evaluate vofatamab for treatment of metastatic bladder cancer.

Fierce 21 is designed to compare vofatamab alone or in combination with docetaxel versus docetaxel alone for patients with locally advanced or metastatic disease with FGFR3 mutations or fusions who relapsed after or were refractory to least one prior line of chemotherapy.

Fierce 22 is designed to evaluate vofatamab in combination with the anti-PD-1 therapy pembrolizumab (Keytruda, Merck) for patients with locally advanced or metastatic disease who progressed after platinum-based chemotherapy but have not received prior immune checkpoint inhibitor therapy.

Another trial — Fierce 23 — is planned to evaluate vofatamab monotherapy for patients with nonmuscle-invasive bladder cancer. That trial is expected to start later this year.