Janssen submits sNDA to FDA for full approval of Balversa
The Janssen Pharmaceutical Companies of Johnson & Johnson has announced the submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for full approval of Balversa (erdafitinib) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC).
The drug received Breakthrough Therapy Designation from the FDA in 2018 as well as gaining accelerated approval in 2019 for the treatment of 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.
This sNDA submission hopes to satisfy regulatory requirements in order to confirm clinical benefit of the drug based on data from cohort 1 of the phase 3 THOR trial. The trial met its primary endpoint of overall survival (OS) with patients who received the drug achieving a median OS of over one year at the prespecified interim analysis data cutoff.
Peter Lebowitz, MD PhD, global therapeutic area head, Oncology at Janssen Research and Development, commented: “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.”
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