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 Eli Lilly.
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
- Hematology · IDH Inhibition
- Sub-indication
- General
Related signal: Eli Lilly initiates Phase 1 trial of oral IDH inhibitor LY3410738 in hematologic malignancies