FDAsafety guidance72% confidence
Ongoing | Cancer Accelerated Approvals
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to 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 · PD-1 Inhibition
- Sub-indication
- General
Related signal: KEYTRUDA Shows Significant PFS Improvement in dMMR Endometrial Cancer in Phase 3 Trial