FDAsafety guidance92% confidence
FDA approves palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of HR-positive, HER2-positive metastatic breast cancer
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (her2) as Roche; the shared HER2 mechanism makes the regulatory bar more directly transferable.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Oncology · Breast Cancer
- Sub-indication
- HER2
Related signal: Phase II Study of HER2 Imaging as Biomarker for T-DM1 in Advanced Breast Cancer