FDAsafety guidance54% confidence
Ongoing | Cancer Accelerated Approvals
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (bladder cancer) as Merck.
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 · Bladder Cancer
- Sub-indication
- Bladder Cancer
Related signal: European Commission Approves KEYTRUDA Plus Padcev for Cisplatin-Ineligible Bladder Cancer