The European Commission (EC) has approved BALVERSA®▼ (erdafitinib) as a once-daily oral monotherapy for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (mUC), harbouring susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alterations, who have previously received at least one line of therapy containing a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor in the unresectable or metastatic treatment setting.1
The approval is based on THOR results, showing a 36% reduction in risk of death with erdafitinib vs chemotherapy.2
Europe has the highest rate of bladder cancer compared to all continents globally, with nearly a quarter of a million people diagnosed in 2022,3 representing a 10% increase from 2020.4
Urothelial carcinoma (UC) is the most common form of bladder cancer,5 and up to 20% of patients with mUC have FGFR alterations.6
Prognosis remains particularly poor for patients with mUC, with only 8% of people diagnosed at a late metastatic stage surviving for five years.7,8
In June 2023, based on the recommendation of the independent data safety monitoring committee, the THOR study was stopped following the interim efficacy analysis and all patients randomised to chemotherapy (docetaxel or vinflunine) were offered the opportunity to receive erdafitinib as crossover therapy.2
The results demonstrate that a median overall survival (OS) of over one year was achieved in patients receiving erdafitinib at the data cut-off, marking a significant improvement as compared to those in the chemotherapy arm.1
Treatment with erdafitinib also showed an improvement in median progression-free survival (PFS) compared to chemotherapy of 5.6 months vs 2.7 months and confirmed overall response rate (ORR) of 35.3% vs 8.5%.1
Yohann Loriot, M.D., Ph.D., Institut Gustave Roussy and University of Paris-Saclay, France* said: “Bladder cancer is one of Europe’s most common cancers and the need for innovative treatment options for people living with unresectable or metastatic urothelial carcinoma remains high. Erdafitinib is a novel, targeted therapy that has been shown to significantly improve overall and progression-free survival for patients with FGFR3 alterations, who, until now, have had limited options available.”
References:
1. Balversa® (erdafitinib). Summary of Product Characteristics. Accessed August 2024.
2. Loriot Y, et al. Phase 3 THOR study: Results of erdafitinib (erda) versus chemotherapy (chemo) in patients (pts) with advanced or metastatic urothelial cancer (mUC) with select fibroblast growth factor receptor alterations (FGFRalt). J Clin Oncol 2023;41(17). Available at: https://doi.org/10.1200/JCO.2023.41.17_suppl.LBA4619. Accessed August 2024.
3. Globocan 2022. Europe Cancer Factsheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/30-bladder-fact-sheet.pdf. Accessed August 2024.
4. Globocan 2020. Europe Cancer Factsheet. Available at: https://gco.iarc.fr/today/data/factsheets/populations/908-europe-fact-sheets.pdf. Accessed August 2024.
5. Cancer.net. Bladder cancer: introduction. Available at: https://www.cancer.net/cancer-types/bladder-cancer/introduction#:~:text=Urothelial%20carcinoma%20(or%20UCC)%20accounts,that%20line%20the%20urinary%20tract. Accessed August 2024.
6. Fernandez E, et al. Prognostic value and clinical significance of FGFR genomic alterations (GAs) in metastatic urothelial cancer patients. J Clin Med 2022;11(15):4483.
7. Cancer.gov. Bladder Cancer Prognosis and Survival Rates – NCI (2023). Available at: https://www.cancer.gov/types/bladder/survival. Accessed August 2024.
8. Montazeri K & Bellmunt J. Erdafitinib for the treatment of metastatic bladder cancer. Expert Review of Clinical Pharmacology. 2020;13(1):1-6.
*Professor Loriot has not been paid for any media work.
