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 tarlatamab.
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 · Bispecific Antibodies
- Sub-indication
- HER2
Related signal: Novel CD2-targeted bispecific antibody enhances T cell engagers for solid tumors
Source
FDA document
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