Janssen seeks USFDA full approval for Balversa for Urothelial Carcinoma

Raritan: The Janssen Pharmaceutical Companies of Johnson & Johnson has announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking full approval of BALVERSA (erdafitinib), a kinase inhibitor, for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) that has susceptible fibroblast growth factor receptor (FGFR)3 genetic alterations, and progressed during or following at least one line of a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor in the locally advanced or metastatic setting or within 12 months of neoadjuvant or adjuvant therapy.

BALVERSA received Breakthrough Therapy Designation from the U.S. FDA in 2018 and received accelerated approval in 2019 for the treatment of adults with locally advanced or mUC which has susceptible FGFR3 or FGFR2 genetic alterations and who have progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

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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