(News Bulletin 247) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Supplemental New Drug Application (sNDA) to the United States Food and Drug Administration (FDA) seeking the full approval of Balversa® (erdafitinib), for the treatment of adults with a certain type of locally advanced or metastatic urothelial carcinoma (mUC).
Balversa® received Breakthrough Therapy designation from the US FDA in 2018 and received accelerated approval in 2019.
“Balversa continues to generate promising clinical results for patients with metastatic FGFR-impaired urothelial cancer, who often face poor outcomes,” said Peter Lebowitz, Global Therapeutic Area Head of Oncology at Janssen Research & Development.
“Through the continued development of this targeted therapy, we are committed to transforming bladder cancer treatment to positively impact patients’ lives,” he added.
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