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 (liver cancer) as Shanghai Junshi Bioscience.
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 · HCC
- Sub-indication
- Liver Cancer
Related signal: Phase III Trial of Toripalimab and Lenvatinib for Advanced HCC Initiated