DACOGEN (decitabine), antimetabolite

Insufficient clinical benefit to justify reimbursement for the treatment of newly diagnosed acute myeloid leukaemia in adults, regardless of age, not eligible for standard induction chemotherapy

• DACOGEN has now been granted a marketing authorisation for the treatment of adults aged under 65 years suffering from newly diagnosed de novo or secondary acute myeloid leukaemia (AML), and not eligible for standard induction chemotherapy. Previously, the marketing authorisation only applied to patients aged over 65 years.

• For patients aged 65 and over, a lack of superiority of DACOGEN in terms of overall survival over conventional treatments (low-dose cytarabine and/or supportive care only) has been demonstrated.

• For adults aged under 65 years, no new relevant data are available.

• Therefore, regardless of the patient's age, DACOGEN has no role in the therapeutic strategy for newly diagnosed AML in cases ineligible for standard induction chemotherapy.

• The higher risk of febrile neutropoenia, thrombocytopoenia and pneumonia than with cytarabine or supportive care should be taken into account.