Vofatamab Granted Designation by FDA for Bladder Cancer Subset


FDA –United States Food & Drug Administration has recently granted designation to Vofatamab for treating metastatic or advanced urothelial cell carcinoma –known for harboring FGFR3 (fibroblast growth factor receptor 3) mutation or fusion.

Vofatamab is a type of antibody that is known for targeting FGFR3 (fibroblast growth factor receptor 3) –a well-known driver bladder cancer along with other forms of malignancies.  Scott Myers – CEO & Chairman of Rainier Therapeutics in a company-released press release stated, “The fast track designation of the antibody serves to be a great hope on the pretext of the immense medical need for treating bladder cancer.”  He added, “As Vofatamab is the only antibody that is known for specifically targeting FGFR3 in modern clinical development, we have the confidence that Vofatamab can turn out to be a promising therapeutic treatment in the case of bladder cancer.  Currently, we are looking forward to obtaining further data from the ongoing trials while we are working towards boosting the overall development efforts.”


In the present scenario, two medical trials are underway towards evaluating Vofatamab in its effectiveness of treating metastatic or advanced bladder cancer.

In the first trial, Fierce 21 has been designated for comparing vofatamab antibody alone as well as in combination with Docetaxel Vs. Docetaxel alone for the patients out there who have locally metastatic or advanced disease.  In this trial, the antibody is worked upon FGFR3 fusions or mutations on the patients whose disease has relapsed after at least one series of chemotherapy.

In the second trial, Fierce 22 has been designated for evaluating Vofatamab by combining it with the anti-PD-1 therapy pembrolizumab for the patients who have locally metastatic or advanced disease and for whom the disease progressed after the chemotherapy based on platinum.

Another ongoing trial “Fierce 23” is aimed at evaluating Vofatamab monotherapy over the patients who tend to have a non-muscle-invasive form of bladder cancer.  This clinical trial might start out later during this year.

Given the series of clinical trials determining the overall effectiveness of Vofatamab, the patients with bladder cancer can look forward to receiving a treatment soon enough.

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