SMC Approves Johnson & Johnson's Balversa for Bladder Cancer

Johnson & Johnson (J&J) recently announced that its innovative bladder cancer medication, Balversa (erdafitinib), has gained approval from the Scottish Medicines Consortium (SMC). This approval allows the drug to be used within the National Health Service (NHS) in Scotland for treating a particular group of urothelial cancer (UC) patients. Specifically, Balversa is intended for adults with unresectable or metastatic UC who possess certain FGFR3 genetic alterations and have previously undergone at least one line of therapy involving a PD-1 or PD-L1 inhibitor.

The SMC's endorsement of Balversa follows the earlier recommendation by the National Institute for Health and Care Excellence to use the drug within the NHS in England and Wales for the same group of patients. This decision was significantly influenced by the encouraging outcomes of the phase 3 THOR clinical trial. In this study, Balversa demonstrated the ability to prolong overall survival from 7.8 months to 12.1 months compared to standard chemotherapy in second-line treatment settings. Furthermore, it improved progression-free survival rates, extending them to 5.6 months versus 2.7 months with chemotherapy, and exhibited a confirmed objective response rate of 35.3% as opposed to 8.5% for chemotherapy.

John Fleming, the UK country medical director for J&J Innovative Medicine, expressed that the SMC's approval "means that eligible UC patients across the UK can now access this first in class treatment option." He highlighted that this development "marks a significant step forward for the bladder cancer community."

Bladder cancer affects nearly 1,700 individuals in Scotland annually, with urothelial cancer, originating from the innermost layer of the bladder, accounting for over 90% of these cases. Among patients with metastatic UC, approximately 20% exhibit an FGFR3 alteration, which is linked to cancer progression and poor prognosis.

Balversa is an oral medication taken once daily, targeting the growth of cancer cells expressing FGFR3. It stands out as the sole treatment option accessible in the UK for patients with this specific type of cancer. Professor Rob Jones, an expert in clinical cancer research at the University of Glasgow, commented on the significance of this development: "This is good news for patients with incurable forms of bladder cancer, as it adds an additional line of life-prolonging treatment for some patients." He further explained that the drug's suitability for patients with specific genetic alterations allows for precise patient selection, thereby minimizing the exposure of other patients to unnecessary side effects from an ineffective treatment.