FDAsafety guidance83% confidence
Cancer Clinical Trial Eligibility Criteria: Performance Status
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to AstraZeneca.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Oncology · ADC
- Sub-indication
- General
Related signal: Sonesitatug vedotin shows significant survival benefit in advanced gastric cancers