FDAapproval54% confidence
Withdrawn | Cancer Accelerated Approvals
Source: FDA
Why This Matters
Why this matters: sets a approval precedent in the same sub-indication (prostate cancer) as Bayer.
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includes accelerated approvals (AAs) for malignant hematology and oncology indications that have been subsequently withdrawn, and are therefore, no longer FDA-approved.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 · Prostate Cancer
- Sub-indication
- Prostate Cancer
Related signal: Bayer's Study on Darolutamide in Advanced Prostate Cancer to Assess Real-World Effectiveness