FDAsafety guidance54% 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 AstraZeneca.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Oncology · ADC
- Sub-indication
- Breast Cancer
Related signal: Datroway approved in US as first TROP2-directed ADC for 1L triple-negative breast cancer