FDAapproval95% confidence
FDA approves gedatolisib with fulvestrant, with or without palbociclib, for HR-positive, HER2-negative locally advanced or metastatic breast cancer
Source: FDA
Why This Matters
Why this matters: sets a approval precedent in the same sub-indication (breast cancer) as Eli Lilly; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Oncology · CDK4/6 Inhibitor
- Sub-indication
- Breast Cancer
Related signal: FDA Accepts Supplemental Application for Verzenio (Abemaciclib)