PMDAapproval72% confidence
[SHINSA]English Translation of Review Report: Blenrep, Neffy, and Tecentriq (Partial Change Approval)
Source: PMDA
Why This Matters
Why this matters: sets a approval precedent in the same sub-indication (her2) as Enhertu recommended for EU approval in HER2+ metastatic solid tumours.
Regulatory Analysis
PMDA document relevant to the signal.
Supporting Context
- Therapeutic area
- Oncology · HER2-positive solid tumours
- Sub-indication
- HER2
Related signal: Enhertu recommended for EU approval in HER2+ metastatic solid tumours