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 Eli Lilly.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Oncology · RET fusion-positive lung cancer
- Sub-indication
- Lung Cancer
Related signal: Lilly's Retevmo shows 83% reduction in disease recurrence for early-stage RET fusion-positive lung cancer