FDAsafety guidance72% confidence
FDA AP — ENHERTU (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to radiation therapy companies.
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 · Radiation Therapy
- Sub-indication
- General
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