J&J’s Bladder Cancer Drug Gets Accelerated FDA Approval

Balversa (erdafitinib) is the first personalized treatment for patients with metastatic bladder cancer that have FGFR genetic mutations.


Balversa (erdafitinib) from Johnson & Johnson is a fibroblast growth factor receptor (FGFR) inhibitor developed for the treatment of patients with metastatic bladder cancer that also have FGFR genetic mutations. FGFRs play important roles in cell growth and division during tissue repair and development.


The U.S. Food and Drug Administration granted Balversa breakthrough therapy designation in 2018 and recently rewarded the drug with an accelerated approval.


According to the director of the Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research Richard Pazdur, erdafitinib is the first personalized treatment targeting susceptible FGFR genetic alternations for patients with metastatic bladder cancer.


The agency’s decision was based on the results of clinical trials showing that over 30% of patients had a partial (30%) or complete (2.3%) response to treatment with erdafitinib, and these responses lasted on average for 5.5 months. Notably, responses were even observed in patients that did not respond to anti PD-L1/PD-1 therapy, which is the current standard of care.

Cynthia A. Challener, Ph.D.

Dr. Challener is an established industry editor and technical writing expert in the areas of chemistry and pharmaceuticals. She writes for various corporations and associations, as well as marketing agencies and research organizations, including That’s Nice and Nice Insight.