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 following failed combination chemotherapy or relapse within six months of adjuvant therapy, especially after anthracycline treatment. The approval details dosage, administration, and adjustments for hepatic impairment and severe adverse events. Common adverse reactions are listed. Efficacy data from a randomized trial showed Abraxane had a higher target lesion response rate than paclitaxel injection, though no overall survival benefit. The report also covers safety, drug interactions, and use in specific populations. An email from Frank H. Cross Jr. to Renu Vaish on December 20, 2011, regarding proposed labeling for Abraxane (NDA 021660/S-025, S-026, S-029) is included, with 14 pages of draft labeling withheld due to confidential commercial information.
Key findings — cited to the page
| Grade 3 peripheral neuropathy in ABRAXANE arm | 10 % | ABRAXANE · p.14 |
| Grade 3 or 4 GGT elevations in ABRAXANE arm | 14 % | ABRAXANE · p.14 |
| Grade 3 or 4 GGT elevations in paclitaxel injection arm | 10 % | paclitaxel injection · p.14 |
| Infectious episodes in ABRAXANE arm | 24 % | ABRAXANE · p.12 |
| Supplemental New Drug Application (sNDA) S-026 approval | revised labeling in the Physican Labeling Rule format | ABRAXANE · p.4 |
| Supplemental New Drug Application (sNDA) S-029 approval | inclusion of three adverse events: Stevens-Johnson syndrome, toxic epidermal necrolysis and extravasation in Section 6, ADVERSE REACTIONS of the Package Insert and minor administrative, editorial and grammatical revisions throughout the Package Insert. | ABRAXANE · p.4 |
| Supplemental New Drug Application (sNDA) S-025 approval | inclusion of pyrexia, dehydration, pancytopenia, congestive heart failure, and left ventricular dysfunction in Section 6, ADVERSE REACTIONS | ABRAXANE · p.4 |
| Neutrophil count threshold for administration | 1,500 cells/mm3 | ABRAXANE · p.9 |
| Dose reduction for severe neutropenia or severe sensory neuropathy (first reduction) | 220 mg/m2 | ABRAXANE · p.9 |
| Dose reduction for severe neutropenia or severe sensory neuropathy (second reduction) | 180 mg/m2 | ABRAXANE · p.9 |
| Most common adverse reactions (incidence) | ≥ 20% | ABRAXANE · p.9 |
| Recommended dosage | 260 mg/m2 | 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 →