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FDA Grants Erdafitinib Breakthrough Designation for Urothelial Carcinoma

Jason Harris
Published: Thursday, Mar 15, 2018

Peter F. Lebowitz, MD, PhD

Peter F. Lebowitz, MD, PhD
The FDA has granted a breakthrough therapy designation to erdafitinib for the treatment of metastatic urothelial carcinoma, according to Janssen, the manufacturer of the oral pan-FGFR tyrosine kinase inhibitor.

gene alterations. The open-label trial has an estimated enrollment of 630 participants, with a planned primary completion date of November 2020. The primary endpoint is OS.
Loriot Y, Necchi A, Park SH, et al. Erdafitinib (ERDA; JNJ-42756493), a pan-fibroblast growth factor receptor (FGFR) inhibitor, in patients (pts) with metastatic or unresectable urothelial carcinoma (mUC) and FGFR alterations (FGFRa): Phase 2 continuous versus intermittent dosing. 2018 Genitourinary Cancers Symposium; February 8-10, 2018; San Francisco, Calif. Abstract 411.

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