Astellas Pharma Inc. — Padcev EMA EPAR variation assessment report (EMEA/H/C/005392, 2022)
Astellas Pharma Inc. · 2022 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes Astellas Pharma's Type II variation application for Padcev (enfortumab vedotin) plus pembrolizumab for first-line locally advanced or metastatic urothelial cancer, based on the KEYNOTE-A39/EV-302 study. The application includes SmPC updates and a 1-year market protection extension. Non-clinical and clinical PK/PD, environmental risk, and exposure-response analyses are detailed. The pivotal Phase 3 EV-302 trial demonstrated superior efficacy (OS, PFS, ORR, DoR) and a consistent safety profile compared to chemotherapy, with no new safety signals. The positive benefit-risk assessment supports the marketing authorization extension.
Key findings — cited to the page
| Pneumonitis ILD (Grade 3-4) | 2.5 % | · p.154 |
| ≥Grade 3 AEs | 78.8 % | · p.154 |
| Peripheral neuropathy (Grade 3-4) | 5.1 % | · p.154 |
| Hyperglycaemia (Grade 3-4) | 0.7 % | · p.154 |
| ≥Grade 3 AEs | 75.4 % | · p.154 |
| Neutropenia (Grade 3-4) | 30.0 % | · p.154 |
| Severe cutaneous reactions (Grade 3-4) | 3.4 % | · p.154 |
| Severe cutaneous reactions (Grade 3-4) | 0.2 % | · p.154 |
| Peripheral neuropathy (Grade 3-4) | 0 % | · p.154 |
| Hyperglycaemia (Grade 3-4) | 8.2 % | · p.154 |
| Neutropenia (Grade 3-4) | 5.9 % | · p.154 |
| Pneumonitis ILD (Grade 3-4) | 0 % | · p.154 |
Source: Astellas Pharma Inc. ↗ · 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 →