DACOGEN

The actual benefit is substantial in the indication in the Marketing Authorisation.

In view of :

- an observed therapeutic effect primarily on complete remission, without a demonstrated impact on overall survival, and

- the restriction in treatment options at this stage of the disease and that may be mainly represented by supportive care alone,
the Transparency Committee considers that DACOGEN provides a minor improvement in actual benefit (level IV) in the treatment strategy of adult patients aged 65 years and above with newly diagnosed de novo or secondary acute
myeloid leukaemia (AML), according to the World Health Organisation (WHO)
classification, who are not candidates for standard induction chemotherapy.