MHRA approves Johnson & Johnson's Balversa for bladder cancer

Johnson & Johnson (J&J) has revealed that its pan-FGFR tyrosine kinase inhibitor, Balversa (erdafitinib), has been granted marketing approval by the Medicines and Healthcare products Regulatory Agency (MHRA) for a specific group of bladder cancer patients.

Balversa has been approved for use as an oral monotherapy for adults with unresectable or metastatic urothelial carcinoma (UC), the predominant form of bladder cancer, who possess susceptible FGFR3 genetic variations. Eligible patients are those who have already undergone at least one round of therapy involving a PD-1 or PD-L1 inhibitor in treating unresectable or metastatic conditions.

In the UK, bladder cancer affects approximately 10,500 individuals annually, with UC making up over 90% of the cases. Among patients with metastatic UC, up to 20% exhibit an FGFR3 alteration, a genetic change that can promote the growth of cancer cells.

The MHRA's decision to approve Balversa follows closely on the heels of the European Commission's approval for the same use, less than three months earlier. The approval was largely supported by positive outcomes from cohort one of the late-stage THOR trial.

Results from the trial indicated that patients treated with J&J’s Balversa had a median overall survival rate of 12.1 months, compared to 7.8 months for those receiving chemotherapy. Additionally, Balversa improved progression-free survival, with 5.6 months compared to 2.7 months for chemotherapy. The drug also showed a confirmed objective response rate of 35.3%, significantly higher than the 8.5% response rate for chemotherapy.

John Fleming, Country Medical Director at J&J Innovative Medicine UK, expressed his satisfaction with the MHRA's decision, stating: "We are delighted that the MHRA has recognised the value that [Balversa] could bring to eligible patients with metastatic UC… We look forward to progressing with health technology assessment submissions for [Balversa] in the coming months, with the view to enabling eligible patients to access [Balversa] through the NHS as soon as possible.”

This approval comes on the heels of the National Institute for Health and Care Excellence’s (NICE) recent recommendation of another J&J drug, Tecvayli (teclistamab), for treating relapsed and refractory multiple myeloma (RRMM) in adults. The final draft guidance, issued last month, applies to RRMM patients in England and Wales who have undergone at least three lines of therapy, including an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody, and have shown progression on their most recent treatment.

The MHRA’s decision to authorize Balversa provides a new treatment option for those battling with specific genetic forms of bladder cancer, marking a significant step forward in precision medicine for this challenging disease.