Dacogen

Dacogen is approved for the treatment of patients with myelodysplastic syndromes (MDS) and acute myeloid leukaemia. The Marketing Authorisation status is approved, with a CHMP positive opinion date of 19 July 2012. The drug received Orphan medicinal product designation on 8 June 2006.

In efficacy studies, median overall survival was 8.5 months and 5.3 months, with a Hazard Ratio for OS of 0.80 (p-value 0.0437). Another analysis showed median OS of 7.9 months and 4.5 months, with a Hazard Ratio for OS of 0.77 (p-value 0.0109). A further analysis reported median OS of 7.7 months and 5.0 months, with a Hazard Ratio for OS of 0.82 (p-value 0.0373). The median overall survival increase was 2.7 months. The overall survival p-value (first analysis) was 0.1079, and the overall survival HR (post-hoc) was 0.82 (CI 0.68, 0.99).

Safety findings include septic shock (all grades) at 6% and Grade 3-4 septic shock at 4%. Myelosuppression events occurred in 73% of subjects, with Grade 3 or 4 myelosuppression events in 69% of subjects. Discontinuation due to progressive disease (overall) was 212, with 96 in the DACOGEN arm and 116 in the TC arm. Discontinuation due to PD at CCO 2010 was 36%, and due to AE at CCO 2010 was 33%.