FDAapproval95% 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: sets a approval precedent in the same sub-indication (bladder cancer) as Astellas; the shared ADC mechanism makes the regulatory bar more directly transferable; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Oncology · ADC
- Sub-indication
- Bladder Cancer
Related signal: FDA grants priority review for PADCEV supplemental application