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 Merck.
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 · Non-small Cell Lung Cancer
- Sub-indication
- Lung Cancer
Related signal: Intismeran Autogene Plus Pembrolizumab Trial for NSCLC Initiated by Merck and Moderna