FDAsafety guidance65% 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 Enhertu recommended for EU approval in HER2+ metastatic solid tumours.
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 · HER2-positive solid tumours
- Sub-indication
- HER2
Related signal: Enhertu recommended for EU approval in HER2+ metastatic solid tumours
Source
FDA document
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