FDAsafety guidance83% confidence
Ongoing | Cancer Accelerated Approvals
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Roche.
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 · KRAS Inhibitor
- Sub-indication
- General
Related signal: Phase I/II Study of GDC-7035 in Advanced Solid Tumors with KRAS G12D Mutation