Unknown MAH — Dacogen EMA EPAR public assessment report (EMEA/H/C/002221, 2012)
Unknown MAH · 2012 · EMA EPAR public assessment report
Report summary
This report summarizes the European marketing authorization assessment for Dacogen (decitabine) for newly diagnosed acute myeloid leukemia (AML) in adults. Dacogen, an orphan medicinal product, had prior authorization in other regions for myelodysplastic syndromes. Non-clinical studies revealed genotoxic, carcinogenic, and reproductive toxicity concerns. Pharmacokinetic and pharmacodynamic properties were detailed. The pivotal Phase III study (DACO-016) compared Dacogen to patient's choice treatment (supportive care or low-dose cytarabine) in older AML patients. Sensitivity analyses showed Dacogen reduced mortality risk. While Dacogen demonstrated superior overall survival (median 2.7 months increase), response rates, and progression-free survival, it was associated with higher rates of adverse events, particularly myelosuppression and infections. The report concludes with regulatory decisions on indication and risk management.
Key findings — cited to the page
| sinusitis (all grades) | 3 % | · p.67 |
| sinusitis (Grade 3-4) | 1 % | · p.67 |
| urinary tract infection (Grade 3-4) | 7 % | · p.67 |
| sepsis (Grade 3-4) | 8 % | · p.67 |
| urinary tract infection (all grades) | 15 % | · p.67 |
| pneumonia (Grade 3-4) | 20 % | · p.67 |
| septic shock (all grades) | 6 % | · p.67 |
| subjects with Grade 3 or 4 myelosuppression event | 69 % | · p.66 |
| septic shock (Grade 3-4) | 4 % | · p.67 |
| sepsis (all grades) | 9 % | · p.67 |
| pneumonia (all grades) | 24 % | · p.67 |
| febrile neutropenia (all grades) | 34 % | · p.67 |
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 →