FDAsafety guidance83% confidence
Ongoing | Cancer Accelerated Approvals
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (ild) as United Therapeutics.
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 · Neuroblastoma
- Sub-indication
- Ild
Related signal: Phase III Trial of Dinutuximab in High-Risk Neuroblastoma Shows Promise