Pfizer Inc. — Ibrance EMA EPAR variation assessment report (EMEA/H/C/003853, 2016)
Pfizer Inc. · 2016 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes the final assessment of pediatric studies for Ibrance (palbociclib) in combination with chemotherapy for relapsed/refractory Ewing sarcoma (EWS) and neuroblastoma (NB). Study A5481092 found no improvement in event-free survival or overall survival in EWS, and the neuroblastoma cohort was terminated due to lack of efficacy. Although no new safety signals emerged, palbociclib increased hematological toxicity and serious infections.
Key findings — cited to the page
| incidence of TEAEs Grade 3-4 (palbociclib arm) | 82.9 % | A5481092 · p.11 |
| incidence of TEAEs Grade 3-4 (control arm) | 81.0 % | A5481092 · p.11 |
| number of participants | 128 | A5481092 · Global · p.7 |
| number of participants in IRN + TMZ arm (Phase 2) | 21 | A5481092 · p.7 |
| number of participants in palbociclib + TOPO + CTX arm (Phase 1) | 26 | A5481092 · p.7 |
| median OS (months) | 13.04 months | A5481092 · p.8 |
| median EFS (months) | 1.5 months | A5481092 · p.8 |
| median OS (months) | 8.54 months | A5481092 · p.8 |
| median EFS (months) | 4.4 months | A5481092 · p.8 |
| HR for EFS | 2.03 | A5481092 · p.9 |
| median OS (months) | 10.68 months | A5481092 · p.10 |
| number of participants in palbociclib + IRN + TMZ arm (Phase 2) | 42 | A5481092 · p.7 |
Source: Pfizer Inc. ↗ · 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 →