BRISTOL-MYERS — Abraxane FDA Review (NDA/BLA 021660, 2015)
Bristol-Myers Squibb Company · 2015 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA approved Abraxane (paclitaxel protein-bound particles) in October 2012 for first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in combination with carboplatin. This approval, based on the pivotal Phase III CA031 trial, demonstrated a statistically significant improvement in overall response rate (ORR) for Abraxane/carboplatin compared to paclitaxel/carboplatin. While the trial met its primary objective of superior ORR, it did not show significant improvements in progression-free survival or overall survival. Safety profiles were generally comparable, with some differences in adverse events. The regulatory strategy involved a 505(b)(2) application, and the FDA granted 3 years of exclusivity.
Key findings — cited to the page
| Alopecia (All Grades) | 56 % | CA 031 · p.90 |
| Anemia (Grade 3 or >) | 28 % | CA 031 · p.90 |
| Fatigue (Grade 3 or >) (control arm) | 4 % | CA 031 · p.90 |
| Nausea (Grade 3 or >) | <1 % | CA 031 · p.90 |
| Grade 3-4 neutropenia in non-small cell lung cancer | 47 % | Abraxane · p.14 |
| Anemia (All Grades) | 98 % | CA 031 · p.90 |
| Calcium (All Grades) | 57 % | CA 031 · p.91 |
| Fatigue (All Grades) (control arm) | 23 % | CA 031 · p.90 |
| Alopecia (Grade 3 or >) | <1 % | CA 031 · p.90 |
| Nausea (All Grades) | 27 % | CA 031 · p.90 |
| Grade 3-4 neutropenia in metastatic breast cancer | 34 % | Abraxane · p.14 |
| Anemia (All Grades) (control arm) | 91 % | CA 031 · p.90 |
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 →