FDAsafety guidance95% confidence
FDA AP — PADCEV (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to AstraZeneca; the shared ADC mechanism makes the regulatory bar more directly transferable.
Regulatory Analysis
Application BLA761137. Sponsor: ASTELLAS. Submission status: AP. Submission type: SUPPL. Review priority: PRIORITY. Active ingredients: ENFORTUMAB VEDOTIN-EJFV.
Supporting Context
- Therapeutic area
- Oncology · ADC
- Sub-indication
- General
Related signal: Sonesitatug vedotin shows significant survival benefit in advanced gastric cancers