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 Sharp & Dohme LLC.
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 · ADC
- Sub-indication
- General
Related signal: Merck and Daiichi Sankyo Trial of Ifinatamab Deruxtecan in Advanced Esophageal Cancer