Johnson & Johnson’s (J&J) bladder cancer drug Balversa (erdafitinib) has been granted full approval by the US Food and Drug Administration.
The oral FGFR kinase inhibitor, which originally received accelerated approval by the FDA in 2019, is now fully authorised for use in adults with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy.
The drug is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-(L)1 inhibitor therapy, the company outlined.
Urothelial carcinoma accounts for approximately 90% of bladder cancer cases, and up to 20% of patients diagnosed with metastatic urothelial carcinoma have FGFR3 genetic alterations.
Despite most urothelial carcinomas being diagnosed at an early stage, rates of recurrence and disease progression are high, and a significant proportion of patients who undergo surgery will experience disease recurrence.
The supplemental New Drug Application for Balversa was supported by results from cohort one of the phase 3 THOR trial, which demonstrated the clinical benefit of the drug in extending overall survival compared to chemotherapy.
The study met its primary endpoint of overall survival, with Balversa treatment showing a 36% reduction in the risk of death versus chemotherapy in patients with metastatic or unresectable urothelial carcinoma and selected FGFR gene alterations who had received prior treatment with an anti-PD-L1 agent.
Kiran Patel, vice president, clinical development, solid tumours, J&J Innovative Medicine, said: “Based on results from randomised phase 3 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 confirms the role of targeted therapy in the treatment of bladder cancer.”
The approval comes less than two weeks after J&J said it would be acquiring antibody drug conjugates (ADC) specialist Ambrx Biopharma for approximately $2bn.
Through the acquisition, the company will gain access to a prostate-specific membrane antigen-targeting ADC for metastatic castration-resistant prostate cancer, an ADC targeting human epidermal growth factor receptor 2 for metastatic HER2-positive breast cancer, and a candidate targeting CD-70 for renal cell carcinoma.