FDA grants regular approval for Balversa

Last Friday, the US Food and Drug Administration (FDA) approved Balversa (erdafitinib), from healthcare giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen. ff

The drug is authorized for adult patients with locally-advanced or metastatic urothelial carcinoma (mUC) – a bladder cancer - with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test, whose disease has progressed on or after at least one line of prior systemic therapy.

Janssen noted that Balversa is the first oral FGFR kinase inhibitor to be approved, and the first and only targeted treatment for patients with mUC and FGFR alterations, explaining that this FDA action converts the April 2019 accelerated approval of Balversa to a full approval based on the clinical and overall survival benefit observed in the Phase III THOR study.