FDAmanufacturing / CMC54% confidence
Other | Cancer Accelerated Approvals
Source: FDA
Why This Matters
Why this matters: sets a manufacturing / CMC precedent in the same sub-indication (lung cancer) as Sichuan Baili Pharmaceutical.
Regulatory Analysis
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have been granted for supportive care products and changes to dosing or formulation.
Supporting Context
- Therapeutic area
- Oncology · Non-small Cell Lung Cancer
- Sub-indication
- Lung Cancer
Related signal: Phase II Study of BL-B01D1 with PD-1 Antibody in Advanced Lung Cancer and Other Tumors