Astellas Pharma Inc. — Padcev FDA Review (BLA761137, ORIG 1, 2019)
Astellas Pharma Inc. · 2019 · FDA Review (openFDA) · company profile →
Report summary
This multi-disciplinary review evaluates Astellas Pharma's BLA 761137 for PADCEV (enfortumab vedotin-ejfv), seeking accelerated approval for locally advanced/metastatic urothelial cancer patients previously treated with PD-1/PD-L1 inhibitors and platinum chemotherapy. The review covers regulatory details, therapeutic context, and nonclinical safety, highlighting toxicities like skin, bone marrow, and liver issues, and genotoxic potential. Clinical pharmacology confirms the recommended 1.25 mg/kg dose. Efficacy data from the single-arm EV-201 study (Cohort 1) show favorable objective response rates. Safety analysis details treatment-emergent adverse events, including rash, neuropathy, and hyperglycemia, with most being manageable. Postmarketing requirements include confirmatory trial data.
Key findings — cited to the page
| Hyperglycemia (Grade 2) | 4.6 % | EV-201 All Cohorts · p.219 |
| Hyperglycemia (Grade 2) | 3.5 % | Enfortumab Vedotin 1.25 mg/kg All · p.219 |
| Hyperglycemia (Grade 1) | 3.9 % | EV-201 All Cohorts · p.219 |
| Hyperglycemia (Grade 2) | 4.8 % | EV-201 Cohort 1 · p.219 |
| Hyperglycemia (Grade 2) | 3.7 % | EV-201 Cohort 2 · p.219 |
| ALT increased (all grades) | 34 % | All 1.25 mg/kg · p.210 |
| Hyperglycemia (Grade 1) | 3.2 % | EV-201 Cohort 1 · p.219 |
| Hyperglycemia (Grade 1) | 7.4 % | EV-201 Cohort 2 · p.219 |
| Hyperglycemia (Grade 1) | 4.5 % | All Enfortumab Vedotin · p.219 |
| Hyperglycemia (Grade 1) | 4.8 % | Enfortumab Vedotin 1.25 mg/kg All · p.219 |
| Lipase increased (Grade 3-4) | 9 % | Cohort 1 · p.211 |
| Hyperglycemia (Grade 2) | 3.2 % | All Enfortumab Vedotin · p.219 |
Source: Astellas Pharma Inc. ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →