FDAapproval65% confidence
Withdrawn | Cancer Accelerated Approvals
Source: FDA
Why This Matters
Why this matters: provides agency context on approval that may shape timing or evidence expectations for GSK.
Regulatory Analysis
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have been subsequently withdrawn, and are therefore, no longer FDA-approved.
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