Erdafitinib Gains FDA Breakthrough Designation for Urothelial Cancer


Pan-fibroblast growth factor receptor tyrosine kinase inhibitor demonstrates efficacy in urothelial cancer.

Janssen recently announced that the FDA has granted breakthrough therapy designation to its investigational drug erdafitinib for the treatment of metastatic urothelial cancer, according to a press release.

Erdafitinib is an oral pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor that is currently in phase 2 and phase 3 clinical trials of urothelial cancer. Janssen reported that FGFRs are tyrosine kinases that may be overexpressed in some tumor cell types and involved with tumor cell differentiation, proliferation, tumor angiogenesis, and cancer cell survival.

The new designation is based on findings from a phase 2 clinical trial evaluating the safety and efficacy of erdafitinib in adults with urothelial cancer. All patients had locally advanced or metastatic disease with tumors that have FGFR mutations.

The researchers found that patients with relapsed/refractory metastatic urothelial cancer with FGFR mutations had an overall response rate of 42%, according to the release.

Urothelial cancer typically affects the bladder but may also occur in the ureter, urethra, or urachus. This type of cancer is the sixth most common in the United States, according to Janssen. Due to the aggressiveness of urothelial cancer, there are a lack of effective treatment options for these patients.

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Janssen entered into an exclusive agreement with Astex Therapeutics Ltd. to develop and commercialize erdafitinib, according to the release.

“For patients diagnosed with urothelial cancer, outcomes are unfortunately disheartening due to the aggressiveness of the disease,” said Peter Lebowitz, MD, PhD, Global Therapeutic Area head, Oncology, Janssen Research and Development, LLC. “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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