FDAsafety guidance72% confidence
FDA AP — KEYTRUDA (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to pembrolizumab.
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 · Immunotherapy
- Sub-indication
- General
Related signal: Pembrolizumab Trial for Small Cell Carcinoma of Ovary - Hypercalcemic Type