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 Boehringer Ingelheim.
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 · Combination Therapy
- Sub-indication
- General
Related signal: Boehringer Ingelheim Initiates Dose-Exploration Study of BI 1831169 with Anti-PD1 in Advanced Cancer