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 (lung cancer) as Sichuan Baili Pharmaceutical Co., Ltd..
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 · NSCLC
- Sub-indication
- Lung Cancer
Related signal: Phase II/III Trial of BL-B01D1 with Osimertinib in EGFR-mutant NSCLC Initiated