FDAsafety guidance77% confidence
FDA AP — ENHERTU (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (lung cancer) as Daiichi Sankyo; the same agency is already in play for this signal, so precedent weight is higher.
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 · Small Cell Lung Cancer
- Sub-indication
- Lung Cancer
Related signal: Ifinatamab Deruxtecan Receives Priority Review for ES-SCLC in the U.S.