Bristol-Myers Squibb Company — Sprycel EMA EPAR variation assessment report (EMEA/H/C/000709, 2006)
Bristol-Myers Squibb Company · 2006 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes the assessment of an addendum to pediatric study CA180372 for Sprycel (dasatinib) in newly diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL). The addendum provides updated long-term (up to 7 years) growth, development, and overall survival (OS) data. While a downward trend in height was observed, there was no significant impact on weight, BMI, or other growth parameters. The assessment confirms the long-term OS benefit of dasatinib in this pediatric population.
Key findings — cited to the page
| Subjects with at least 1 post-baseline z-score <= -2 in DXA scans | 35 | CA180372 · p.10 |
| Treatment-related adverse events associated with bone growth and development | 1 | SPRYCEL · p.11 |
| Overall survival (OS) at 5 years after last dose | 79.4 % | CA180372 · p.11 |
| Procedure number | EMEA/H/C/000709/P46/048 | Sprycel · p.1 |
| Study number | CA180372 | · p.3 |
| Study type | Phase 2, open-label, single-arm, historically-controlled | CA180372 · p.4 |
| Age range of subjects | > 1 to < 18 years of age | CA180372 · p.4 |
| Treatment duration | 2 years | CA180372 · p.4 |
| Dasatinib dose | 60 mg/m2 daily | CA180372 · p.4 |
| Subjects enrolled | 109 | CA180372 · p.4 |
| Subjects treated with dasatinib | 106 | CA180372 · p.4 |
| Subjects with at least one DXA scan assessment post-baseline | 99 | CA180372 · p.10 |
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 →