FDAapproval65% 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 approval precedent in the same sub-indication (liver cancer) as Shanghai Junshi Bioscience.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Oncology · HCC
- Sub-indication
- Liver Cancer
Related signal: Phase III Trial of Toripalimab and Lenvatinib for Advanced HCC Initiated