Astellas Pharma Inc. — Padcev EMA EPAR public assessment report (EMEA/H/C/005392, 2022)
Astellas Pharma Inc. · 2022 · EMA EPAR public assessment report · company profile →
Report summary
The EMA assessed Padcev (enfortumab vedotin) for locally advanced or metastatic urothelial cancer. Manufacturing, quality, and stability of its components were confirmed. Preclinical studies detailed its pharmacology, pharmacokinetics, and toxicology, identifying target organs and potential adverse effects like testicular toxicity. Clinical trials, notably EV-301, demonstrated superior efficacy over chemotherapy, with significantly improved overall survival (12.9 vs 9.0 months) and progression-free survival (5.6 vs 3.7 months). Key adverse events included skin reactions, peripheral neuropathy, and hyperglycemia, with management strategies outlined. The report covers dose selection, DDI studies, and effects of renal/hepatic impairment.
Key findings — cited to the page
| TEAEs with NCI-CTCAE ≥ Grade 3 | 68.8 % | Enfortumab Vedotin 1.25 mg/kg (overall) · p.139 |
| Drug-related TEAEs with NCI-CTCAE ≥ Grade 3 | 56.0 % | Enfortumab Vedotin Cohort 1 (EV-201) · p.139 |
| TEAEs with NCI-CTCAE ≥ Grade 3 | 66.3 % | Chemotherapy (EV-301) · p.139 |
| TEAEs with NCI-CTCAE ≥ Grade 3 | 69.7 % | Enfortumab Vedotin Cohort 2 (EV-201) · p.139 |
| Drug-related TEAEs with NCI-CTCAE ≥ Grade 3 | 51.4 % | Enfortumab Vedotin (EV-301) · p.139 |
| Drug-related TEAEs with NCI-CTCAE ≥ Grade 3 | 49.8 % | Chemotherapy (EV-301) · p.139 |
| Nausea (Chemo, all grades) | 25.4 % | Study EV-301 · p.186 |
| TEAEs with NCI-CTCAE ≥ Grade 3 | 70.9 % | Enfortumab Vedotin (EV-301) · p.139 |
| Nausea (Padcev, Grade 3*) | 1.0 % | Study EV-301 · p.186 |
| TEAEs with NCI-CTCAE ≥ Grade 3 | 74.4 % | Enfortumab Vedotin Cohort 1 (EV-201) · p.139 |
| Nausea (Chemo, Grade 3*) | 1.7 % | Study EV-301 · p.186 |
| Drug-related TEAEs with NCI-CTCAE ≥ Grade 3 | 55.1 % | Enfortumab Vedotin Cohort 2 (EV-201) · p.139 |
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 →