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) in combination with gemcitabine on September 6, 2013, for the first-line treatment of metastatic adenocarcinoma of the pancreas. This approval was based on Study CA-046, a randomized trial demonstrating statistically significant improvements in overall survival (median 8.5 vs 6.7 months), progression-free survival, and objective response rate compared to gemcitabine alone. While efficacy was robust, the combination therapy showed significant safety concerns, including higher rates of neutropenia, fatigue, peripheral neuropathy, sepsis, and pneumonitis. Common adverse reactions and dose-limiting toxicities necessitated specific dose adjustment guidelines for hepatic impairment and adverse events. Despite some protocol amendments and GCP issues, the FDA concluded that the overall survival effect was statistically robust, supporting regular approval. ABRAXANE is also approved for metastatic breast cancer and non-small cell lung cancer.
Key findings — cited to the page
| Grade 3-4 fatigue (Abraxane/gemcitabine) | 18% | · p.52 |
| Grade 3-4 peripheral neuropathy (gemcitabine alone) | 1% | · p.52 |
| Grade 3-4 neutropenia (Abraxane/gemcitabine) | 38% | · p.52 |
| Grade 3-4 thrombocytopenia (gemcitabine alone) | 9% | · p.52 |
| Grade 3-4 fatigue (gemcitabine alone) | 9% | · p.52 |
| Grade 3-4 peripheral neuropathy (Abraxane/gemcitabine) | 17% | · p.52 |
| anemia (all grades) in Gemcitabine arm | 33 % | CA046 · p.87 |
| incidence of rash (all grades) | 10 % | · p.194 |
| Grade 3-4 neutropenia (gemcitabine alone) | 27% | · p.52 |
| Grade 3-4 thrombocytopenia (Abraxane/gemcitabine) | 13% | · p.52 |
| pyrexia (all grades) in Gemcitabine arm | 29 % | CA046 · p.87 |
| Grade 3-4 dehydration (Abraxane/gemcitabine) | 7% | · p.52 |
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 →