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FDA grants breakthrough therapy designation to erdafitinib for metastatic urothelial carcinoma
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The FDA granted breakthrough therapy designation to erdafitinib for the treatment of metastatic urothelial cancer, according to the agent’s manufacturer.
Erdafitinib — developed and commercialized as part of a collaboration agreement between Janssen and Astex Therapeutics — is an oral pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor.
FGFRs are a family of receptor tyrosine kinases that may be upregulated in various tumor cell types. They also may contribute to tumor cell proliferation and differentiation, tumor angiogenesis and tumor cell survival.
Phase 2 and phase 3 clinical trials are underway to evaluate the agent as treatment for patients with advanced urothelial cancer, the sixth most common type of cancer in the United States.
The FDA based the breakthrough therapy designation on results from a multicenter, open-label phase 2 trial designed to evaluate erdafitinib for the treatment of adults with locally advanced or metastatic urothelial cancer whose tumors have certain FGFR genetic alterations.
Results showed a 42% overall response rate among 59 patients with relapsed or refractory metastatic urothelial cancer whose tumors harbored actionable FGFR mutations.
“For patients diagnosed with urothelial cancer, outcomes are unfortunately disheartening due to the aggressiveness of the disease,” Peter Lebowitz, MD, PhD, global therapeutic area head of oncology at Janssen Research and Development, said in a press release. “Through the continued development of erdafitinib, and working closely with the FDA, we look forward to bringing a potential new treatment option to patients.”