FDAsafety guidance66% confidence
FDA AP — PADCEV (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for AstraZeneca; the same agency is already in play for this signal, so precedent weight is higher.
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 · AKT Inhibitor
- Sub-indication
- General
Related signal: AstraZeneca's Capivasertib NDA218197 Receives AP Status from FDA