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Balversa FDA Approval History

FDA Approved: Yes (First approved April 12, 2019)
Brand name: Balversa
Generic name: erdafitinib
Dosage form: Tablets
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Urothelial Carcinoma

Balversa (erdafitinib) is a pan-fibroblast growth factor receptor (FGFR) inhibitor for the treatment of patients with locally advanced or metastatic urothelial cancer (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy.

Development timeline for Balversa

DateArticle
Jan 19, 2024Approval U.S. Food and Drug Administration Grants Full Approval for Balversa to Treat Locally Advanced or Metastatic Bladder Cancer with Select Genetic Alterations
Apr 12, 2019Approval FDA Approves Balversa (erdafitinib) for the Treatment of Metastatic Bladder Cancer
Sep 18, 2018Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Erdafitinib for the Treatment of Metastatic Urothelial Cancer
Jun  3, 2018Erdafitinib Phase 2 Study Results Show Promise in the Treatment of Metastatic Urothelial Cancer
Mar 15, 2018Janssen Announces U.S. FDA Breakthrough Therapy Designation for Erdafitinib in the Treatment of Metastatic Urothelial Cancer

See also

Balversa (erdafitinib) Consumer information

Further information

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