First treatment for common bladder cancer recommended by NICE

Johnson & Johnson’s Balversa was found to extend the lives of urothelial cancer patients with a genetic alteration

Balversa (erdafitinib) has been recommended for use on the NHS as the first and only treatment in the UK for urothelial cancer (UC) involving a fibroblast growth factor receptor (FGFR3) alteration, which affects up to one in five patients with advanced disease. The drug slows tumour growth, advancing time in treatment and improving quality of life.

Eligible patients will have unresectable or metastatic disease and will have previously received at least one line of therapy containing a programmed death receptor-1 or programmed death-ligand inhibitor.

Developed by global pharma company Johnson & Johnson, Balversa was recommended by the National Institute for Health and Care Excellence (NICE) based on the THOR study. It found that Balversa increased overall survival from 7.8 months to 12.1 months compared to standard care chemotherapy in the second-line setting. It works by inhibiting or even stopping FGFR3-expressing cancer cell growth.

“We are delighted to have reached this outcome for people living with advanced urothelial cancer,” said John Fleming, UK Medical Director of Johnson & Johnson.

The treatment is highly accessible, taken once-a-day orally from the comfort of the patients’ own home.

Urothelial cancer makes up more than 90% of bladder cancers. Patients with an FGR3 alteration have a particularly poor prognosis and have previously not had any targeted therapies available to them on the NHS, demonstrating the need for innovative therapies such as Balversa.

The approval is celebrated by interim CEO of Fight Bladder Cancer, Melanie Costin, as a “transformative moment” and “significant step forward in care”.

She said: “Additionally, we hope this opens the door for more targeted clinical trials through genetic testing, and drives us forward to the time that every patient has access to therapies designed specifically for them.”

The British Uro-oncology Group added that the recommendation “marks a step-change improvement in the management of urothelial cancer” and is “a welcome advance”.