Teva B V — Trisenox EMA EPAR variation assessment report (EMEA/H/C/000388, 2002)
Teva B V · 2002 · EMA EPAR variation assessment report · company profile →
Report summary
This report assesses Trisenox (arsenic trioxide) for pediatric use, primarily in relapsed/refractory acute promyelocytic leukemia (APL) and other solid tumors. While promising efficacy was observed in pediatric APL, no benefit was seen in neuroblastoma or non-APL leukemias. Safety profiles were generally comparable to adults, but concerns regarding long-term toxicity and higher pediatric doses were raised. The submitted pediatric data, mainly from trials CTI-1059 and T-99-080, were deemed insufficient for a formal Type II variation for indication modification. A decision on indication modification requires more reliable and exhaustive data, as final data from CALGB C9710 are still pending.
Key findings — cited to the page
| number of children enrolled | 64 children | CALGB C9710 · p.10 |
| overall CR rate for adults | 89 % | CALGB C9710 · p.10 |
| nausea, vomiting, cough and cancer pain | 35 % | CTI 1059 · p.6 |
| constipation | 16 % | T99 080 · p.9 |
| hypomagnesemia | 26 % | T99 080 · p.9 |
| nausea/vomiting | 26 % | T99 080 · p.9 |
| abdominal pain | 10 % | T99 080 · p.9 |
| hypocalcemia | 26 % | T99 080 · p.9 |
| morphological complete response (APL patients) | 11 out of 13 patients | T99 080 · p.9 |
| cytogenetic response | 9 out of 11 patients | T99 080 · p.9 |
| number of adults enrolled | 518 adults | CALGB C9710 · p.10 |
| CR rate for children | 89 % | CALGB C9710 · p.10 |
Source: Teva B V ↗ · 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 →