FDAsafety guidance83% confidence
FDA AP — ENHERTU (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (her2) as Roche.
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 · Breast Cancer
- Sub-indication
- HER2
Related signal: Phase II Study of HER2 Imaging as Biomarker for T-DM1 in Advanced Breast Cancer