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FDA Grants Fast Track Designation to Vofatamab for FGFR3+ Bladder Cancer

Lisa Astor
Published Online:7:14 PM, Fri January 11, 2019
This week the FDA granted a fast track designation to the novel targeted therapy vofatamab for the treatment of patients with advanced or metastatic urothelial carcinoma who harbor an FGFR3 alteration, according to Rainier Therapeutics, the company developing vofatamab.

“This Fast Track designation underscores the great unmet medical need that exists for the treatment of bladder cancer,” said Scott Myers, chairman and CEO of Rainier Therapeutics, in a statement. “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.”

Vofatamab, formerly known as B-701, is a novel monoclonal antibody targeted at FGFR3. Approximately 15% to 20% of patients with advanced bladder cancer have tumors harboring an FGFR3 mutation or fusion.

In previous preclinical and phase I trials, the agent was suggested to be able to enhance the efficacy of agents treating patients with urothelial carcinoma.

The fast track program from the FDA facilitates the accelerated development and review of drugs that are designed to treat serious conditions that may fill a current unmet medical need. This designation will allow for Rainier Therapeutics, formerly called BioClin Therapeutics, to meet with the FDA more regularly to aid in the development plan for vofatamab.

“Fast Track designation offers the potential to reduce development time and cost associated with bringing a drug to patients,” Valerie Fauvelle, vice president of regulatory affairs, Rainier Therapeutics, said in a statement. “We look forward to working with the FDA to rapidly advance vofatamab through the clinical development and regulatory processes.”

The agent is currently being tested in 2 phase I/II clinical trials with a third trial expected to begin recruiting later in the year.

The first trial, known as FIERCE-21, is a dose-escalation and -expansion study of the investigational agent as a monotherapy or in combination with docetaxel chemotherapy in patients with stage IV, locally advanced, or metastatic urothelial cell carcinoma who have relapsed or are refractory to prior treatment with at least 1 chemotherapy regimen and who harbor an FGFR3 mutation and/or fusion (NCT02401542). 

Preliminary results from this trial demonstrated the safety and efficacy of the agent in combination with docetaxel, especially in patients with an FGFR3 mutation and/or fusion compared with wild-type patients. 

The multicenter, open-label FIERCE-22 trial is investigating the combination of vofatamab plus pembrolizumab (Keytruda) in patients with locally advanced or metastatic urothelial cell carcinoma who have progressed after treatment with platinum-based chemotherapy and have never received an immune checkpoint inhibitor (NCT03123055).

Rainier Therapeutics noted that the FIERCE-23 trial is planned to start in 2019 and will be evaluating vofatamab as a single-agent in patients with non–muscle invasive bladder cancer.  
Bellmunt J, Picus J, Kohli M, et al. FIERCE-21: Phase 1b/2 study of docetaxel + b-701, a selective inhibitor of FGFR3, in relapsed or refractory (R/R) metastatic urothelial carcinoma (mUCC). J Clin Oncol. 2018;36(suppl; abstr 4534).

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