FDAsafety guidance66% 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 safety guidance precedent in the same sub-indication (bladder cancer) as Merck; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Oncology · Bladder Cancer
- Sub-indication
- Bladder Cancer
Related signal: FDA Approves Pembrolizumab Combinations for Muscle Invasive Bladder Cancer