FDAsafety guidance83% confidence
FDA AP — ONTRUZANT (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (her2) as DB Pharma.
Regulatory Analysis
Application BLA761100. Sponsor: SAMSUNG BIOEPIS CO LTD. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: TRASTUZUMAB-DTTB.
Supporting Context
- Therapeutic area
- Oncology · Breast Cancer
- Sub-indication
- HER2
Related signal: DB-1303/BNT323 Trial in HER2-Low Metastatic Breast Cancer Initiated