FDAapproval54% confidence
Verified Clinical Benefit | Cancer Accelerated Approvals
Source: FDA
Why This Matters
Why this matters: sets a approval 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 with postmarketing trials that have verified clinical benefit and for which traditional approval has been subsequently granted for the specific indication.
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