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
Astellas Pharma Inc. submitted a Type II variation for Padcev (enfortumab vedotin) plus pembrolizumab for neoadjuvant/adjuvant treatment of cisplatin-ineligible muscle-invasive bladder cancer (MIBC). The pivotal KEYNOTE-905/EV-303 study demonstrated significant improvements in event-free survival and overall survival. While efficacy was favorable, the combination showed a high incidence of manageable treatment-emergent and serious adverse events, consistent with known safety profiles. The environmental risk assessment concluded no significant environmental risk. The report details the regulatory process, clinical study design, efficacy, and safety data, including specific adverse events like skin reactions and peripheral neuropathy.
Key findings — cited to the page
| Percentage of participants with toxicity grade 3-5 adverse events | 40.5 % | KEYNOTE-905 · p.81 |
| Percentage of participants with toxicity grade 3-5 adverse events | 46.0 % | · p.81 |
| Percentage of participants with toxicity grade 3-5 adverse events | 71.3 % | KEYNOTE-905 · p.81 |
| Participants with toxicity grade 3-5 adverse events | 98 | KEYNOTE-905 · p.81 |
| Percentage of participants with toxicity grade 3-5 adverse events | 77.1 % | · p.81 |
| Participants with toxicity grade 3-5 adverse events | 3514 | · p.81 |
| Participants with toxicity grade 3-5 adverse events | 565 | · p.81 |
| Participants with toxicity grade 3-5 adverse events | 119 | KEYNOTE-905 · p.81 |
| Participants with toxicity grade 3-5 adverse events | 116 | KEYNOTE-905 · p.81 |
| Percentage of participants with toxicity grade 3-5 adverse events | 71.2 % | KEYNOTE-905 · p.81 |
| Participants with toxicity grade 3-5 adverse events | 435 | · p.81 |
| Participants with toxicity grade 3-5 drug-related adverse events | 76 | KEYNOTE-905 · p.81 |
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 →