Johnson & Johnson has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for BALVERSA ® ▼ (erdafitinib) as a monotherapy for the treatment of adults with unresectable or metastatic urothelial carcinoma (UC), the most common form of bladder cancer. Specifically, the indication covers eligible patients harboring susceptible fibroblast growth factor receptor 3 ( FGFR3 ) genetic alterations, who have previously received at least one line of therapy containing a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor in the unresectable or metastatic treatment setting. Approximately 10,500 people in the UK are diagnosed with bladder cancer every year, which equates to 29 people per day.
Around 20 percent of people with advanced or metastatic bladder cancer have FGFR3 alterations, which can drive the growth of cancer cells. “Patients living with this advanced stage of bladder cancer, and whose tumors harbor FGFR3 alterations, require access to innovative precision therapies that can target the specific characteristics of their disease,” said Professor Alison Birtle, Consultant Oncologist and Honorary Clinical Professor, Lancashire Teaching Hospitals NHS Foundation Trust. “Unfortunately, until now, there have been limited treatment options available for this group of patients, which may affect not only their prognosis , but their wellbeing and quality of life.
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