FDAsafety guidance72% confidence
FDA AP — KEYTRUDA QLEX (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Merck.
Regulatory Analysis
Application BLA761467. Sponsor: MERCK SHARP DOHME. Submission status: AP. Submission type: SUPPL. Review priority: PRIORITY. Active ingredients: PEMBROLIZUMAB, BERAHYALURONIDASE ALFA-PMPH.
Supporting Context
- Therapeutic area
- Oncology · Sarcoma
- Sub-indication
- General
Related signal: Phase III Trial of Pembrolizumab Plus Doxorubicin in Aggressive Sarcomas