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 Novartis.
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 · Breast Cancer
- Sub-indication
- HER2
Related signal: Novartis initiates Phase I/II trial for ERW316 in HR+/HER2- breast cancer