In a Phase III THOR study, J&J’s BALVERSA treatment demonstrated a significant clinical and overall survival benefit. Credit: Konektus Photo / Shutterstock.com.

Johnson & Johnson (J&J) has received full approval from the US Food and Drug Administration (FDA) for BALVERSA (erdafitinib) to treat locally advanced or metastatic urothelial carcinoma (mUC) with susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alterations.

The treatment is indicated for use in adult patients whose disease advanced on or following at least one line of systemic treatment.

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The approval, which follows an accelerated approval in April 2019, is based on the randomised, open-label, controlled, multicentre Phase III THOR study in which it demonstrated a significant clinical and overall survival benefit.

Patients treated with BALVERSA experienced a median overall survival extension of more than four months compared to those who received chemotherapy.

A 36% decline in mortality risk was observed with BALVERSA compared to chemotherapy.

BALVERSA is not recommended for patients who are eligible to receive and have not been treated with a programmed death 1 or programmed death-ligand 1 inhibitor therapy.

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BALVERSA is the first oral FGFR kinase inhibitor to obtain full FDA approval to treat mUC with FGFR alterations.

In September 2023, the company filed a marketing authorisation application with the European Medicines Agency for BALVERSA for the same indication.

Janssen Pharmaceuticals, a unit of J&J, signed a global licence and partnership agreement with Astex Pharmaceuticals for the development and marketing of BALVERSA in 2008.

Johnson & Johnson Innovative Medicine solid tumours clinical development vice-president Kiran Patel stated: “Based on results from randomised Phase III data, BALVERSA continues to demonstrate the promise of targeted therapy in the treatment of patients with advanced bladder cancer.

“This important milestone reinforces our commitment to advance innovative, precision therapies in oncology and confirm the role of targeted therapy in the treatment of bladder cancer.”

This month, the company entered a definitive agreement to acquire Ambrx Biopharma in a $2bn all-cash deal.