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# Janssen Seeks Full Approval for Balversa
- URL: https://www.fdaweb.com/janssen-seeks-full-approval-for-balversa/
- Published: 2023-08-29T12:00:00.000Z
- Updated: 2026-09-14T18:53:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155198

Janssen Pharmaceutical has submitted a supplemental NDA that is seeking to convert Balversa’s (erdafitinib) 2019 accelerated approval to full approval. The drug is indicated for treating adult patients with locally advanced or metastatic urothelial carcinoma that has susceptible fibroblast growth factor receptor genetic alterations, and progressed after receiving a programmed death receptor-1 or programmed death-ligand 1 inhibitor in the locally advanced or metastatic setting or within 12 months of neoadjuvant or adjuvant therapy.

The submission is based on data from the confirmatory Phase 3 THOR ([NCT03390504](https://clinicaltrials.gov/ct2/show/NCT03390504?ref=fdaweb.com)) study, which met its primary endpoint of overall survival (OS), “with patients who received Balversa achieving a median OS of over one year at the prespecified interim analysis data cutoff,” according to the company. “As the interim results met the predefined criteria for superiority of treatment with Balversa over chemotherapy, the independent data safety monitoring committee recommended that the study be stopped, and that patients randomized to chemotherapy be offered the opportunity to cross over to Balversa.