The sNDA filing was based on the data from Cohort 1 of the late-stage THOR trial in which Balversa met the primary endpoint of overall survival with patients achieving a median OS of over one year
The FDA granted accelerated approval for Balversa for the mUC indication in 2019. (Credit: The U.S. Food and Drug Administration/Wikimedia Commons)
Janssen Pharmaceutical Companies of Johnson & Johnson has filed a supplemental New Drug Application (sNDA) for full approval of Balversa (erdafitinib) to the US Food and Drug Administration (FDA) for the treatment of certain types of patients with locally advanced or metastatic urothelial carcinoma (mUC).
Balversa is a once-daily, oral fibroblast growth factor receptor (FGFR) kinase inhibitor.
Janssen is pursuing full approval for the kinase inhibitor as a treatment for mUC patients with eligible FGFR3 genetic alterations. This applies to those whose condition has progressed after at least one round of a programmed death-ligand 1 (PD-L1) inhibitor or programmed death receptor-1 (PD-1) inhibitor in the locally advanced or metastatic context, or within a year of neoadjuvant or adjuvant therapy.
Balversa secured Breakthrough Therapy Designation from the FDA in 2018 and obtained accelerated approval in 2019 for the mUC indication.
The sNDA filing was based on the data from Cohort 1 of the Phase 3 THOR trial. The submission of the application is expected to meet the regulatory obligations to confirm the therapeutic benefit of the kinase inhibitor, Janssen said.
THOR is a randomised, open-label, multicentre study with a goal to assess the efficacy and safety of Balversa.
In the trial, the therapy met its primary endpoint of overall survival (OS), with patients who were administered with the kinase inhibitor achieving a median OS of over 12 months at the prespecified interim analysis data cutoff.
Janssen Research & Development oncology global therapeutic area head Peter Lebowitz said: “Balversa continues to generate promising clinical findings for patients with FGFR-altered metastatic urothelial cancer, who often face poor disease outcomes.
“Through the ongoing development of this targeted therapy, we are committed to transforming bladder cancer treatment to positively impact the lives of patients.”
Since the interim results met the predetermined criteria establishing the superiority of Balversa treatment over chemotherapy, the independent data safety monitoring committee advised discontinuing the study. It was also suggested that patients initially assigned to chemotherapy should have the option to switch to the FGFR kinase inhibitor.