FDAapproval72% confidence
Withdrawn | Cancer Accelerated Approvals
Source: FDA
Why This Matters
Why this matters: sets a approval precedent in the same sub-indication (her2) as AstraZeneca.
Regulatory Analysis
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have been subsequently withdrawn, and are therefore, no longer FDA-approved.
Supporting Context
- Therapeutic area
- Oncology · ADC
- Sub-indication
- HER2
Related signal: Enhertu Secures EU Approval as First Tumour Agnostic HER2 Therapy