FDAapproval95% confidence
Verified Clinical Benefit | Cancer Accelerated Approvals
Source: FDA
Why This Matters
Why this matters: sets a approval precedent in the same sub-indication (her2) as palbociclib; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications with postmarketing trials that have verified clinical benefit and for which traditional approval has been subsequently granted for the specific indication.
Supporting Context
- Therapeutic area
- Oncology · Breast Cancer
- Sub-indication
- HER2
Related signal: FDA approves gedatolisib with fulvestrant for HR-positive, HER2-negative breast cancer