FDAsafety guidance72% confidence
Cancer Clinical Trial Eligibility Criteria: Performance Status
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (lung cancer) as Sichuan Baili Pharmaceutical Co., Ltd..
Regulatory Analysis
Supporting Context
- Therapeutic area
- Oncology · NSCLC
- Sub-indication
- Lung Cancer
Related signal: Phase II/III Trial of BL-B01D1 with Osimertinib in EGFR-mutant NSCLC Initiated