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 (melanoma) as Roche.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Oncology · NRAS-mutant Melanoma
- Sub-indication
- Melanoma
Related signal: Genentech's Belvarafenib Trial in NRAS-mutant Advanced Melanoma Initiated