FDAsafety guidance66% 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 (colorectal cancer) as Roche; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Oncology · Immunotherapy
- Sub-indication
- Colorectal Cancer
Related signal: FDA Grants Priority Review for Roche’s Tecentriq in Stage III Colon Cancer