Bristol-Myers Squibb Company — Abraxane EMA EPAR variation assessment report (EMEA/H/C/000778, 2008)
Bristol-Myers Squibb Company · 2008 · EMA EPAR variation assessment report · company profile →
Report summary
This report details a Type II variation application for Abraxane (paclitaxel) to update its SmPC with new pediatric pharmacokinetic, efficacy, and safety data from the ABI-007-PST-001 study. This Phase 1/2 trial evaluated nab-paclitaxel in pediatric patients with recurrent or refractory solid tumors (Ewing's sarcoma, neuroblastoma, rhabdomyosarcoma). Phase 1 determined a recommended Phase 2 dose of 240 mg/m2, with neutropenia and anemia as common adverse events. Phase 2 showed limited efficacy, with low overall response rates and short progression-free survival, indicating further development in these indications is not warranted. Despite limited efficacy, the variation is recommended for approval, maintaining a positive benefit-risk balance. Supplementary information on pharmacokinetics and updated 1-year overall survival data were also provided.
Key findings — cited to the page
| Percentage of patients with treatment-related Grade 3 or 4 neutropenia in Phase 1 | 50 % | Abraxane Phase 1 · p.48 |
| Percentage of patients with treatment-related Grade 3 or 4 anemia in Phase 1 | 20 % | Abraxane Phase 1 · p.48 |
| Percentage of patients with Grade 3 or 4 anemia in Phase 1 | 27 % | Abraxane Phase 1 · p.46 |
| Percentage of patients with Grade 4 leukopenia in Phase 1 | 14 % | Abraxane Phase 1 · p.46 |
| Percentage of patients with treatment-related Grade 3 or 4 leukopenia in Phase 1 | 23 % | Abraxane Phase 1 · p.48 |
| Percentage of patients with treatment-related Grade 3 or 4 lymphopenia in Phase 1 | 13 % | Abraxane Phase 1 · p.48 |
| Percentage of patients experiencing Grade 3 or 4 TEAEs in Phase 1 | 88 % | Abraxane Phase 1 · p.43 |
| Percentage of patients with Grade 3 or 4 neutropenia in Phase 1 | 53 % | Abraxane Phase 1 · p.46 |
| Percentage of patients with Grade 3 or 4 leukopenia in Phase 1 | 27 % | Abraxane Phase 1 · p.46 |
| Percentage of patients with Grade 4 neutropenia in Phase 1 | 33 % | Abraxane Phase 1 · p.46 |
| Procedure Number | EMEA/H/C/000778/II/0097 | Abraxane · p.1 |
| Percentage of patients with TEAE leading to dose reduction in Phase 1 | 16 % | Abraxane Phase 1 · p.52 |
Source: Bristol-Myers Squibb Company ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →