FDAsafety guidance66% confidence
S9 Nonclinical Evaluation for Anticancer Pharmaceuticals--Questions and Answers
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (breast cancer) as Roche; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Oncology · Breast Cancer
- Sub-indication
- Breast Cancer
Related signal: FDA Accepts NDA for Roche's Giredestrant in Early-Stage ER-Positive Breast Cancer