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# Breakthrough Designation for Janssen Cancer Drug
- URL: https://www.fdaweb.com/breakthrough-designation-for-janssen-cancer-drug/
- Published: 2018-03-15T12:00:00.000Z
- Updated: 2026-09-14T23:53:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140994

FDA has granted Breakthrough Therapy designation for Janssen’s erdafitinib in treating urothelial cancer. A company [statement](https://www.marketwatch.com/story/janssen-announces-us-fda-breakthrough-therapy-designation-for-erdafitinib-in-the-treatment-of-metastatic-urothelial-cancer-2018-03-15/print?ref=fdaweb.com) says the designation is based on data from a multi-center Phase 2 trial of the drug’s efficacy and safety in treating adult patients with locally advanced or metastatic urothelial cancer whose tumors have certain fibroblast growth factor receptor genetic alterations. The study showed an overall response rate of 42% in 59 patients, Janssen says.

Erdafitinib is described as an oral pan-fibroblast growth factor receptor tyrosine kinase inhibitor being evaluated in Phase 2 and 3 trials in patients with advanced urothelial cancer.