FDAsafety guidance65% confidence
FDA AP — ENHERTU (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Merck.
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 Acknowledges Daiichi Sankyo's ADC Manufacturing Update