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 summarizes a Type II variation application for Trisenox (arsenic trioxide) to expand its indication for newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL). The application is based on the APL0406 study, a Phase 3 non-inferiority trial comparing ATRA+ATO to standard ATRA and anthracycline-based chemotherapy. Efficacy data from APL0406 and AML17 show high complete remission rates and improved event-free and overall survival with ATRA+ATO, especially in low-to-intermediate-risk APL. While ATRA+ATO demonstrated a more favorable safety profile regarding myelosuppression, it was associated with higher rates of QTc prolongation and hepatotoxicity compared to ATRA+chemotherapy. The report also references various scientific publications and clinical trials supporting the use of ATO and ATRA combinations in APL.
Key findings — cited to the page
| Alopecia (Grade 3) | 3 % | AML17 · p.44 |
| Oral (Grade 3) | 1 % | AML17 · p.44 |
| Nausea (Grade 3) | 0 % | AML17 · p.44 |
| Nausea (Grade 3) | 4 % | AML17 · p.44 |
| Diarrhoea (Grade 3) | 1 % | AML17 · p.44 |
| Diarrhoea (Grade 3) | 6 % | AML17 · p.44 |
| Neurotoxicity (Grade 3-4) at 1st consolidation cycle | 4 % | APL0406 · p.43 |
| Gastrointestinal toxicity (Grade 3-4) at Induction | 2 % | APL0406 · p.43 |
| Neurotoxicity (Grade 3-4) at 3rd consolidation cycle | 6 % | APL0406 · p.43 |
| Neurotoxicity (Grade 3-4) at 2nd consolidation cycle | 5 % | APL0406 · p.43 |
| Alopecia (Grade 3) | 13 % | AML17 · p.44 |
| Oral (Grade 3) | 15 % | AML17 · p.44 |
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 →