Janssen seeks USFDA full approval for Balversa for Urothelial Carcinoma

The sNDA submission for BALVERSA is intended to satisfy the regulatory requirements to confirm the clinical benefit of BALVERSA based on the randomized data from Cohort 1 of the Phase 3 THOR study.

“BALVERSA continues to generate promising clinical findings for patients with FGFR-altered metastatic urothelial cancer, who often face poor disease outcomes,” said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. “Through the ongoing development of this targeted therapy, we are committed to transforming bladder cancer treatment to positively impact the lives of patients.”

The sNDA is based upon data from Cohort 1 of the randomized, controlled, open-label, multicenter Phase 3 THOR (NCT03390504) study evaluating the efficacy and safety of BALVERSA. The study 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. 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. The safety profile of BALVERSA observed in THOR was consistent with the known safety profile of BALVERSA in mUC. Results from Cohort 1 were presented in a Late-Breaking Presentation Session (Abstract # LBA4619) at the 2023 American Society of Clinical Oncology Annual Meeting.

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