FDAsafety guidance72% confidence
Ongoing | Cancer Accelerated Approvals
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (her2) as Jazz Pharmaceuticals.
Regulatory Analysis
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have postmarketing requirement(s) for ongoing clinical trial(s) to verify clinical benefit.
Supporting Context
- Therapeutic area
- Oncology · HER2-positive Breast Cancer
- Sub-indication
- HER2
Related signal: Phase 2 Study of Zanidatamab with Chemotherapy in HER2-positive Breast Cancer