Johnson & Johnson (J&J) has announced that its bladder cancer therapy Balversa (erdafitinib) has been accepted by the Scottish Medicines Consortium (SMC) to treat a subset of urothelial cancer (UC) patients.
The pan-FGFR3 tyrosine kinase inhibitor can now be used on the NHS in Scotland to treat unresectable or metastatic UC in adults who are harbouring susceptible FGFR3 genetic alterations and have received at least one line of therapy containing a PD-1 or PD-L1 inhibitor.
The SMC’s decision comes shortly after the National Institute for Health and Care Excellence recommended that Balversa be used on the NHS in England and Wales for the same indication, and was supported by positive results from the phase 3 THOR trial.
J&J’s drug was shown to increase overall survival from 7.8 months to 12.1 months compared to chemotherapy in the second-line setting. It also demonstrated an improvement in progression-free survival compared to chemotherapy, at 5.6 months versus 2.7 months, and had a confirmed objective response rate of 35.3% versus 8.5% for chemotherapy.
John Fleming, UK country medical director, J&J Innovative Medicine, said the SMC’s acceptance “means that eligible UC patients from across the UK can now access this first in class treatment option”, adding that the news “marks a significant step forward for the bladder cancer community”.
Almost 1,700 people are diagnosed with bladder cancer in Scotland every year and UC, which starts in the innermost lining of the bladder, accounts for more than 90% of cases. As many as 20% of patients with metastatic UC have an FGFR3 alteration, which can drive the growth of cancer cells is associated with a poor prognosis.
Taken orally once daily, J&J’s Balversa is designed to stop or slow the growth of FGFR3-expressing cancer cells, and is the only treatment available in the UK for patients with this specific type of cancer.
“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,” said Rob Jones, professor of clinical cancer research at the University of Glasgow.
He continued: “Moreover, because the treatment is only suitable for patients with specific genetic changes, we can accurately select patients where the treatment is more likely to work. This means we can spare the other patients from the side effects of a treatment which would be ineffective.”