Johnson & Johnson (J&J) has announced that its pan-FGFR tyrosine kinase inhibitor, Balversa (erdafitinib), has been granted marketing authorization by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. This approval marks a significant step forward in the treatment of a specific subset of bladder cancer patients. The drug is indicated as an oral monotherapy for adult patients with unresectable or metastatic urothelial carcinoma (UC), the most common form of bladder cancer, who harbor susceptible FGFR3 genetic alterations and have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic setting.
Clinical Efficacy and Trial Data
The MHRA's decision was based on positive results from cohort one of the late-stage THOR trial. The data demonstrated a clinically meaningful improvement in overall survival for patients treated with Balversa compared to those treated with chemotherapy. Specifically, Balversa showed a median overall survival of 12.1 months, compared to 7.8 months for chemotherapy. The trial also revealed an improvement in progression-free survival, with Balversa demonstrating 5.6 months versus 2.7 months for chemotherapy. Furthermore, the confirmed objective response rate was 35.3% for Balversa, significantly higher than the 8.5% observed with chemotherapy.
Impact on Bladder Cancer Treatment
Approximately 10,500 individuals are diagnosed with bladder cancer annually in the UK, with urothelial carcinoma accounting for over 90% of these cases. Notably, up to 20% of patients with metastatic UC have an FGFR3 alteration, which can drive the growth and proliferation of cancer cells. This approval offers a targeted treatment option for these patients, addressing a critical unmet need in bladder cancer therapy.
Expert Commentary
John Fleming, country medical director, J&J Innovative Medicine UK, stated, "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."
Further Developments
This approval follows the European Commission's decision to approve Balversa for the same indication less than three months prior. It also comes after the National Institute for Health and Care Excellence’s recent recommendation of J&J’s Tecvayli (teclistamab) for relapsed and refractory multiple myeloma, highlighting J&J's continued commitment to advancing cancer care.
