FDAsafety guidance72% 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 (lung cancer) as Roche.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Oncology · Small Cell Lung Cancer
- Sub-indication
- Lung Cancer
Related signal: RAPTOR Trial Evaluates Radiation Therapy with Atezolizumab in Extensive Stage Small Cell Lung Cancer