MHRA grants approval for bladder cancer drug erdafitinib

New therapy targets specific genetic alterations, promises extended survival

Johnson & Johnson has announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved BALVERSA (erdafitinib) for treating adults with unresectable or metastatic urothelial carcinoma (UC) harbouring FGFR3 genetic alterations.

This approval offers a new option for patients who have already undergone at least one line of therapy containing a PD-1 or PD-L1 inhibitor.

Around 10,500 people are diagnosed with bladder cancer annually in the UK, with approximately 20% of those having FGFR3 genetic alterations driving cancer growth.

Professor Alison Birtle of Lancashire Teaching Hospitals NHS Foundation Trust stated, “Patients living with this advanced stage of bladder cancer, and whose tumours harbour FGFR3 alterations, require access to innovative precision therapies that can target the specific characteristics of their disease. Today’s authorisation of erdafitinib will come as welcome news to eligible patients.”

Erdafitinib is an oral FGFR kinase inhibitor shown to extend overall survival compared to chemotherapy.

MHRA’s decision was based on the Phase 3 THOR study, which demonstrated that patients receiving erdafitinib had a median overall survival of 12.1 months compared to 7.8 months for those on chemotherapy.

Progression-free survival was also improved, with a median of 5.6 months versus 2.7 months for chemotherapy.

Dr John Fleming, Country Medical Director at Johnson & Johnson Innovative Medicine UK, expressed enthusiasm for the approval, noting the company’s commitment to advancing cancer treatments. “This milestone reflects J&J’s long-standing dedication to getting in front of cancer and delivering the most innovative precision therapies to patients in need.”

With this approval, Johnson & Johnson aims to work with health authorities to make erdafitinib available through the NHS as soon as possible, providing new hope to patients with advanced bladder cancer.