FDAsafety guidance72% confidence
Ongoing | Cancer Accelerated Approvals
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (lung cancer) as Roche.
Regulatory Analysis
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have postmarketing requirement(s) for ongoing clinical trial(s) to verify clinical benefit.
Supporting Context
- Therapeutic area
- Oncology · KRAS G12C Non-Small Cell Lung Cancer
- Sub-indication
- Lung Cancer
Related signal: Roche's Divarasib Shows Best-in-Class Potential in Phase III NSCLC Trial