BRISTOL-MYERS — Abraxane FDA Review (NDA/BLA 021660, 2019)
Bristol-Myers Squibb Company · 2019 · FDA Review (Drugs@FDA) · company profile →
Report summary
This FDA approval package details Abraxane (paclitaxel protein-bound particles for injectable suspension) approval on December 23, 2011, for metastatic breast cancer. It covers labeling changes, dosage, contraindications, warnings, and adverse reactions like neutropenia and sensory neuropathy. The report also includes safety information, pharmacokinetic data, drug interactions, and specific population considerations. A comparative study showed Abraxane had a higher target lesion response rate than paclitaxel injection, though no overall survival difference. Regulatory supplements S-025 and S-026 addressed safety signal updates and Physician Labeling Rule compliance, including PPI readability and CMC aspects, leading to a CMC approval recommendation.
Key findings — cited to the page
| Grade 3 or 4 elevations in GGT in ABRAXANE arm | 14 % | ABRAXANE · p.14 |
| Neutropenia (Grade 4) in ABRAXANE arm | 9 % | ABRAXANE · p.13 |
| Patients who developed Grade 3 peripheral neuropathy in ABRAXANE arm | 24 patients | ABRAXANE · p.14 |
| Grade 3 or 4 elevations in GGT in paclitaxel injection arm | 10 % | paclitaxel injection · p.14 |
| Neutropenia (Grade 4) in paclitaxel injection arm | 22 % | paclitaxel injection · p.13 |
| Approval Date | December 23, 2011 | ABRAXANE · p.1 |
| 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 |
| Bilirubin level for not receiving ABRAXANE | > 5.0 x ULN | ABRAXANE · p.9 |
| Recommended dosage | 260 mg/m2 | ABRAXANE · p.9 |
| Baseline neutrophil count for ABRAXANE therapy | < 1,500 cells/mm3 | ABRAXANE · p.9 |
| AST level for not receiving ABRAXANE | > 10 x ULN | ABRAXANE · p.9 |
| Supplement Number | S-026 | Abraxane · p.34 |
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 →