Unknown MAH — Balversa EMA EPAR public assessment report (EMEA/H/C/006050, 2024)
Johnson & Johnson · 2024 · EMA EPAR public assessment report · company profile →
Report summary
This report summarizes the marketing authorization application for Balversa (erdafitinib) by Janssen-Cilag International N.V. for treating locally advanced unresectable or metastatic urothelial carcinoma with FGFR3 genetic alterations. The European Medicines Agency (EMA) granted a positive opinion on June 27, 2024, based on comprehensive regulatory, clinical, and non-clinical data. Erdafitinib, an oral pan-FGFR tyrosine kinase inhibitor, demonstrated significant improvements in overall survival, progression-free survival, and objective response rates compared to chemotherapy in the pivotal BLC3001 study. Its manufacturing, quality, and non-clinical pharmacology, toxicology, and pharmacokinetic profiles were thoroughly assessed. While adverse events, including eye, nail, and skin disorders, were common, they were generally manageable. The report concludes with a positive benefit-risk assessment, supporting the marketing authorization for this biomarker-selected therapy addressing an unmet medical need.
Key findings — cited to the page
| Grade 3 or 4 TEAEs | 64 % | BLC3001 · p.165 |
| study treatment related grade 3 or 4 TEAEs | 12.1 % | BLC3001 Cohort 2 · p.137 |
| Incidence of Grade ≥1 CSR and Grade ≥2 GI disorders (p-value) | <0.001 | · p.86 |
| grade 3 or 4 TEAEs | 50.9 % | BLC3001 Cohort 2 · p.137 |
| study treatment related grade 3 or 4 TEAEs | 44.5 % | BLC3001 Cohort 1 and Cohort 2 · p.137 |
| study treatment related grade 3 or 4 TEAEs | 46.4 % | BLC3001 Cohort 1 · p.137 |
| study treatment related grade 3 or 4 TEAEs | 45.9 % | mUC Pool · p.137 |
| grade 3 or 4 TEAEs | 67.0 % | mUC Pool · p.137 |
| grade 3 or 4 TEAEs | 64.0 % | BLC3001 Cohort 1 and Cohort 2 · p.137 |
| grade 3 or 4 TEAEs | 64.3 % | BLC3001 Cohort 1 · p.137 |
| grade 3 or 4 TEAEs | 67 % | BLC2001 · p.137 |
| study treatment related grade 3 or 4 TEAEs | 46 % | BLC2001 · p.137 |
Source: Johnson & Johnson ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →