FDAsafety guidance66% 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; the same agency is already in play for this signal, so precedent weight is higher.
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 Inhibitor
- Sub-indication
- HER2
Related signal: FDA Accepts Supplemental Application for PERJETA by Genentech