FDA approves Balversa for bladder cancer treatment
Betsy Goodfellow | January 22, 2024 | News story | Medical Communications | Balversa, FDA, Johnson & Johnson, Oncology, bladder cancer
Johnson & Johnson (J&J) have announced that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Balversa (erdafitinib) for the treatment of 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 one prior treatment.
This FDA decision 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.
Warnings and precautions included in the US Prescribing Information comprise ocular disorders, hyperphosphatemia 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, increases aspartate aminotransferase, fatigue, dry mouth, dry skin, decreased phosphate, decreased appetite, dysgeusia, constipation, increased calcium, dry eyes, palmar-plantar erythrodysesthesia 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.”
Betsy Goodfellow
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