Unknown MAH — Dacogen EMA EPAR variation assessment report (EMEA/H/C/002221, 2012)
Unknown MAH · 2012 · EMA EPAR variation assessment report
Report summary
This report assesses a pediatric study (E773-G000-202) of decitabine as an epigenetic priming agent before induction chemotherapy in pediatric Acute Myelogenous Leukemia (AML). The randomized, open-label trial involved 25 subjects. While the total remission rate (CR+CRi) was similar between the decitabine priming arm (81.8%) and the control arm (85.7%), the morphologic complete remission (CR) rate was lower in the decitabine arm (27.3%) compared to the control arm (50.0%). No new safety signals were identified, but the decitabine arm showed longer times to ANC and platelet recovery. The CHMP concluded that decitabine pretreatment had no effect on clinical response rates or MRD results and did not alter the benefit-risk balance of Dacogen.
Key findings — cited to the page
| patients with at least 1 Grade 3-4 TEAE | 85 % | Study Daco-202 Arm B · p.25 |
| incidence of white blood cell count decreased (Grade 3-4) | 14 subjects | DACO-202 · p.20 |
| Grade 3-4 serum chemistry values (any) | 21.4 % | Study Daco-202 Arm B · p.24 |
| patients with at least 1 Grade 3-4 TEAE | 100 % | Study Daco-202 Arm A · p.25 |
| low (Grade 1-4) postbaseline potassium values | 63.6 % | Study Daco-202 Arm A · p.24 |
| shift in potassium level from Grade 0-2 at Baseline to Grade 3-4 during treatment | 13.8 % | Study DACO-016 decitabine arm · p.24 |
| shift in potassium level from Grade 0-2 at Baseline to Grade 3-4 during treatment | 8.2 % | Study DACO-016 TC arm · p.24 |
| low (Grade 1-4) postbaseline potassium values | 21.4 % | Study Daco-202 Arm B · p.24 |
| Grade 3-4 low potassium values | 54.5 % | Study Daco-202 Arm A · p.24 |
| Grade 3-4 serum chemistry values (any) | 45.4 % | Study Daco-202 Arm A · p.24 |
| Grade 3-4 low potassium values | 7.1 % | Study Daco-202 Arm B · p.24 |
| incidence of febrile neutropenia (Grade 3-4) | 11 subjects | DACO-202 · p.20 |
Source: Unknown MAH ↗ · 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 →