FDAsafety guidance72% confidence
Drug Trials Snapshots: YARTEMLEA
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Roche.
Regulatory Analysis
YARTEMLEA is a prescription drug that is MASP-2 inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA).
Supporting Context
- Therapeutic area
- Oncology · KRAS Inhibitor
- Sub-indication
- General
Related signal: Phase I/II Study of GDC-7035 in Advanced Solid Tumors with KRAS G12D Mutation