BRISTOL-MYERS — Abraxane FDA Review (NDA/BLA 021660, 2019)
Bristol-Myers Squibb Company · 2019 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA approved Abraxane (paclitaxel protein-bound particles) on December 23, 2011, for metastatic breast cancer after chemotherapy failure. This report details its approved indications, dosage, administration, warnings, precautions, and adverse reactions, including neurological, visual, hepatic, and gastrointestinal issues. It also covers drug interactions, use in specific populations (e.g., pregnant women, hepatic impairment), and pharmacokinetic data. A comparative study showed Abraxane had a higher target lesion response rate than paclitaxel injection, though no significant overall survival difference. The report also outlines the regulatory review process, focusing on labeling changes for adverse events and patient information, ensuring consistency with FDA guidelines.
Key findings — cited to the page
| Grade 3 or 4 GGT elevations (ABRAXANE) | 14 % | ABRAXANE · p.14 |
| Grade 3 peripheral neuropathy | 24 patients | ABRAXANE · p.14 |
| Grade 3 or 4 GGT elevations (paclitaxel injection) | 10 % | paclitaxel injection · p.14 |
| Neutropenia (Grade 4) in metastatic breast cancer (comparator) | 22 % | paclitaxel injection · p.13 |
| Neutropenia (Grade 4) in metastatic breast cancer | 9 % | ABRAXANE · p.13 |
| Recommended dosage | 260 mg/m2 | ABRAXANE · p.9 |
| Supplemental New Drug Application (sNDA) approval | S-029 | Abraxane · p.4 |
| Indication | For the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or replase within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. | ABRAXANE · p.1 |
| Infectious episodes | 24 % | ABRAXANE · p.13 |
| Supplemental New Drug Application (sNDA) approval | S-026 | Abraxane · p.4 |
| Hypotension during infusion | 5 % | ABRAXANE · p.14 |
| Neutropenia baseline count threshold | 1,500 cells/mm3 | ABRAXANE · p.9 |
Source: Bristol-Myers Squibb Company ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →