The US Food and Drug Administration (FDA) has awarded breakthrough therapy designation to Janssen Pharmaceutical’s erdafitinib for the treatment of patients with urothelial cancer.
This will fast-track the investigational drug’s development and regulatory review.
Erdafitinib is an oral pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor and is said to be the first targeted candidate for this indication.
It is being jointly developed by Janssen and Astex Therapeutics under an exclusive worldwide licence and collaboration agreement signed by the companies in 2008.
Janssen Research & Development, oncology global therapeutic area head Peter Lebowitz said: “For patients diagnosed with urothelial cancer, outcomes are unfortunately disheartening due to the aggressiveness of the disease.
“Through the continued development of erdafitinib, and working closely with the FDA, we look forward to bringing a potential new treatment option to patients.”
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Janssen is currently assessing erdafitinib in Phase II and III clinical trials for advanced urothelial cancer.
The latest FDA decision is based on findings obtained during a multi-centre, open-label Phase II trial that tested the safety and efficacy of the drug candidate in adults with locally-advanced or metastatic urothelial cancer with FGFR mutations.
Results showed a 42% overall response rate in 59 patients who had relapsed/refractory metastatic urothelial cancer and whose tumours possessed actionable FGFR mutations.
The sixth most common type of cancer in the US, urothelial cancer affects the internal lining of the bladder. It is estimated that 81,190 new cases will be diagnosed this year, leading to 17,240 deaths.