FDAsafety guidance72% confidence
FDA AP — HERCEPTIN HYLECTA (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Amgen.
Regulatory Analysis
Application BLA761106. Sponsor: GENENTECH INC. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: TRASTUZUMAB AND HYALURONIDASE-OYSK.
Supporting Context
- Therapeutic area
- Oncology · Pancreatic Adenocarcinoma
- Sub-indication
- General
Related signal: Gene Amplification Adjacent to F3 Linked to Poor Outcomes in Pancreatic Adenocarcinoma