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 GSK.
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 · Ovarian Cancer
- Sub-indication
- General
Related signal: GSK's Mo-Rez Evaluated in 1L Maintenance for HRd Ovarian Cancer in BEHOLD-Ovarian03 Trial