Johnson & Johnson Secures Complete FDA Approval For Bladder Cancer Drug Balversa, After Almost Five Years Of Accelerated Approval

Friday afternoon, the FDA approved Johnson & Johnson’s JNJ supplemental New Drug Application (sNDA) for Balversa (erdafitinib) for adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. 

Balversa is not recommended for patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy. 

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.

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 3 THOR study. 

In the Phase 3 THOR study, Balversa confirmed the clinical benefit of extending overall survival (OS) compared to chemotherapy in the second-line setting. 

The study showed a 36% reduction in the risk of death with Balversa versus chemotherapy in patients previously treated with a PD-1 or PD-(L)1 inhibitor, with those in the Balversa arm living a median of over four months longer.

In January, Johnson & Johnson agreed to acquire Ambrx Biopharma Inc AMAM in an all-cash merger transaction for a total equity value of approximately $2.0 billion, or $1.9 billion net of estimated cash acquired. Johnson & Johnson will acquire Ambrx for $28.00/share. 

The planned acquisition presents a distinct opportunity for Johnson & Johnson to design, develop, and commercialize targeted oncology therapeutics. 

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Price Action: JNJ shares are up 0.04% at $161.75 on the last check Monday.