Approvals

The approval follows results from the randomised, controlled, open-label, multicentre phase 3 THOR study, which confirmed the clinical benefit of the drug in extending overall survival compared to chemotherapy in second-line treatment.

Warnings and precautions included in the US Prescribing Information comprise ocular disorders, hyperphosphataemia and embryo-foetal toxicity. The most common adverse reactions included increased phosphate, nail disorders, stomatitis, diarrhoea, increased creatinine, increased alkaline phosphate, increased alanine aminotransferase, decreased haemoglobin, decreased sodium, increased aspartate aminotransferase, fatigue, dry mouth, dry skin, decreased phosphate, decreased appetite, dysgeusia, constipation, increased calcium, dry eyes, palmar-plantar erythrodysesthaesia syndrome, increased potassium, alopecia and central serous retinopathy.

Kiran Patel MD, vice president, clinical development, solid tumours at Johnson & Johnson Innovative Medicine, commented: “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 confirm the role of targeted therapy in the treatment of bladder cancer.”

This FDA approval converts the accelerated approval for the drug, which was granted in April 2019, to a full approval, following the clinical and overall survival benefit demonstrated in the phase 3 THOR study.