FDAsafety guidance72% confidence
Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (lung cancer) as Regeneron.
Regulatory Analysis
The purposes of eligibility criteria for cancer clinical trials are to select the intended patient population and reduce potential risks to trial subjects.
Supporting Context
- Therapeutic area
- Oncology · NSCLC
- Sub-indication
- Lung Cancer
Related signal: Regeneron initiates trial for ubamatamab and REGN7075 in advanced NSCLC