FDAsafety guidance83% confidence
FDA AP — ENHERTU (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Merck Sharp & Dohme LLC.
Regulatory Analysis
Application BLA761139. Sponsor: DAIICHI SANKYO. Submission status: AP. Submission type: SUPPL. Review priority: PRIORITY. Active ingredients: FAM-TRASTUZUMAB DERUXTECAN-NXKI.
Supporting Context
- Therapeutic area
- Oncology · ADC
- Sub-indication
- General
Related signal: Merck and Daiichi Sankyo Trial of Ifinatamab Deruxtecan in Advanced Esophageal Cancer