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 (prostate cancer) as Sun Pharma; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Oncology · Hormonal Therapy
- Sub-indication
- Prostate Cancer
Related signal: FDA Accepts Supplemental NDA for YONSA by Sun Pharma