Johnson & Johnson (J&J) has announced that its pan-FGFR tyrosine kinase inhibitor Balversa (erdafitinib) has been granted marketing authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat a subset of bladder cancer patients.
The drug has been approved as an oral monotherapy for adults with unresectable or metastatic cases of urothelial carcinoma (UC), the most common form of the disease, who are harbouring susceptible FGFR3 genetic alterations.
Eligible patients will also have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting.
Approximately 10,500 people are diagnosed with bladder cancer every year in the UK, with UC accounting for more than 90% of cases. Up to 20% of patients with metastatic UC have an FGFR3 alteration, which can drive the growth of cancer cells.
The MHRA’s decision, which comes less than three months after the European Commission approved Balversa for the same indication, was based on positive results from cohort one of the late-stage THOR trial.
J&J’s drug demonstrated a median overall survival of 12.1 months compared to 7.8 months for chemotherapy. It also showed 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% compared to 8.5% for chemotherapy.
John Fleming, country medical director, J&J Innovative Medicine UK, said: “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.”
The approval follows the National Institute for Health and Care Excellence’s recent recommendation of J&J’s Tecvayli (teclistamab) to treat relapsed and refractory multiple myeloma (RRMM) in adults.
The final draft guidance, released last month, applies to RRMM patients in England and Wales who have received at least three lines of therapy, including an immunomodulatory drug, a proteasome inhibitor and an anti-CD38 antibody, and have progressed on their last treatment.