FDAsafety guidance72% 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 (lung cancer) as Roche.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Oncology · KRAS G12C-Positive Non-Small Cell Lung Cancer
- Sub-indication
- Lung Cancer
Related signal: Divarasib Study Targets KRAS G12C-Positive NSCLC Post-Chemoimmunotherapy