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 (her2) as Roche; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Oncology · HER2-positive Breast Cancer
- Sub-indication
- HER2
Related signal: FDA Approves PHESGO Supplement for Genentech's Combination Therapy