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BALVERSA^® is the first and only licensed targeted
therapy used as monotherapy for adult patients with
unresectable or metastatic UC harbouring susceptible
FGFR3 alterations who have previously received at
least one line of therapy with a PD-1 or PD-L1 inhibitor
in the unresectable or metastatic setting.^1–3

Test all patients with unresectable or metastatic UC
who have previously received at least one line of
therapy with a PD-1 or PD-L1 inhibitor in the
unresectable or metastatic setting for FGFR3
alterations, to determine eligibility for BALVERSA^® and unlock the potential of targeted therapy^1*

Click here to view the clinical efﬁcacy
and safety profile of BALVERSA^® in the
registrational THOR study (cohort 1)^†

BALVERSA^® as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible FGFR3 genetic alterations 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 (see section 5.1 of the SmPC).¹

^*Before taking BALVERSA^®, the physician must have confirmation of a susceptible FGFR3 gene alteration determined by a validated test. Treatment should be initiated and supervised by a physician experienced in the use of anticancer therapies.¹

^†The efﬁcacy and safety of BALVERSA^® were evaluated in cohort 1 of a Phase III, randomised, open-label
multicentre study of 266 patients to evaluate the OS of BALVERSA^® vs chemotherapy (docetaxel or
vinﬂunine) in patients with unresectable or metastatic UC harbouring selected FGFR3 alterations, who have
progressed after 1 or 2 prior treatments, at least 1 of which includes a PD-1 or PD-L1 inhibitor.¹

References:

BALVERSA^® (erdafitinib). Summary of Product Characteristics. (3 mg, 4 mg and 5 mg tablets).
Available from: https://www.medicines.org.uk/emc/search?q=balversa.
Siefker-Radtke AO et al. Lancet Oncol. 2022;23(2):248–58.
Loriot Y et al. N Engl J Med. 2023;389(21):1961–71.

Abbreviations

FGFR3, fibroblast growth factor receptor 3; OS, overall survival; PD-1, programmed cell death protein 1;
PD-L1, programmed cell death ligand 1; SmPC, Summary of Product Characterisitcs; UC, urothelial carcinoma.

Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk. Adverse events should also be reported to Johnson & Johnson's Drug Safety Department on 01494 567447 or at dsafety@its.jnj.com.

This is a promotional advertisement developed by Johnson & Johnson and intended for UK healthcare professionals
managing patients with unresectable or metastatic UC.

CP-462133 I September 2025