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 (bladder cancer) as Tyra Biosciences.
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 · Urothelial Carcinoma
- Sub-indication
- Bladder Cancer
Related signal: Tyra Biosciences initiates Phase 2A/B trial of Dabogratinib for Low Grade Upper Tract Urothelial Carcinoma