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 Bristol-Myers Squibb.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Oncology · Immunotherapy
- Sub-indication
- Lung Cancer
Related signal: Phase III Trial of Nivolumab Post-Surgery in Non-Small Cell Lung Cancer