FDAsafety guidance72% 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 Roche.
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 · HER2-positive Breast Cancer
- Sub-indication
- HER2
Related signal: Phase III Trial Compares 6 vs. 12 Months of HER2-Targeted Therapy in Breast Cancer