FDAapproval85% confidence
FDA approves pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph each with enfortumab vedotin-ejfv for muscle invasive bladder cancer
Source: FDA
Why This Matters
Why this matters: provides agency context on approval that may shape timing or evidence expectations for AstraZeneca; the shared ADC mechanism makes the regulatory bar more directly transferable.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Oncology · ADC
- Sub-indication
- General
Related signal: Sonesitatug vedotin shows significant survival benefit in advanced gastric cancers