Lancashire Teaching Hospitals NHS Foundation Trust

Erdafitinib Approved in the UK for Advanced Bladder Cancer with FGFR3 Alterations

6 months ago

• The MHRA has granted marketing authorization for erdafitinib as a monotherapy for adults with unresectable or metastatic urothelial carcinoma (UC) harboring susceptible FGFR3 genetic alterations. • Erdafitinib is indicated for patients who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting. • Phase 3 THOR study results showed that erdafitinib significantly improved overall survival (OS) compared to chemotherapy (12.1 months vs. 7.8 months) in patients with advanced UC and FGFR3 alterations. • Erdafitinib, an oral FGFR kinase inhibitor, offers a targeted approach for bladder cancer patients with specific genetic profiles, addressing a critical unmet need in this population.

Erdafitinib Approved in the UK for Bladder Cancer with FGFR3 Alterations

7 months ago

• The MHRA has approved erdafitinib for adults with unresectable or metastatic urothelial carcinoma (UC) harboring FGFR3 genetic alterations, offering a new treatment option. • Erdafitinib, an oral FGFR kinase inhibitor, demonstrated extended overall survival compared to chemotherapy in the Phase 3 THOR study, with a median overall survival of 12.1 months versus 7.8 months. • The approval provides hope for approximately 20% of bladder cancer patients in the UK who have FGFR3 genetic alterations driving cancer growth, addressing a critical unmet need. • Johnson & Johnson is committed to working with health authorities to make erdafitinib available through the NHS, ensuring access to this innovative precision therapy for eligible patients.