FDAsafety guidance72% confidence
FDA AP — PHESGO (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (her2) as Merck.
Regulatory Analysis
Application BLA761170. Sponsor: GENENTECH INC. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: PERTUZUMAB, TRASTUZUMAB, AND HYALURONIDASE-ZZXF.
Supporting Context
- Therapeutic area
- Oncology · HER2-positive Esophagogastric Adenocarcinoma
- Sub-indication
- HER2
Related signal: Phase II Trial of Pembrolizumab and Trastuzumab in HER2-positive Esophagogastric Adenocarcinoma