FDAsafety guidance83% confidence
FDA AP — KEYTRUDA (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Merck.
Regulatory Analysis
Application BLA125514. Sponsor: MERCK SHARP DOHME. Submission status: AP. Submission type: SUPPL. Review priority: PRIORITY. Active ingredients: PEMBROLIZUMAB.
Supporting Context
- Therapeutic area
- Oncology · PD-1 Inhibition
- Sub-indication
- General
Related signal: KEYTRUDA Shows Significant PFS Improvement in dMMR Endometrial Cancer in Phase 3 Trial