EU approval for Dacogen (Janssen Cilag) for treatment of Acute Myeloid Leukemia

Astex Pharmaceuticals has announced that Janssen-Cilag International NV was notified that the European Commission has approved the marketing authorization for Dacogen (decitabine) for the treatment of adult patients (age 65 years and above) with newly diagnosed de novo or secondary Acute Myeloid Leukemia (AML), according to the World Health Organization (WHO) classification, who are not candidates for standard induction chemotherapy. Dacogen also has been granted Orphan Drug designation for the treatment of AML.

The data in support of the marketing authorization is based on the Phase 3 DACO-016 trial that compared decitabine to patients' choice with physician advice of either supportive care or low-dose cytarabine in the treatment of older patients with AML. The analysis of the protocol-specified results demonstrated an increase of 54 percent in median overall survival in patients taking decitabine (7.7 months for decitabine patients, compared to 5.0 months for patients in the comparator arm; HR=0.85, 95 percent CI: 0.69 to 1.04, p=0.108). An updated analysis of mature survival data confirmed this strong trend for improved overall survival and provided clinically significant evidence of the efficacy of decitabine (HR=0.82; 95 percent CI: 0.68 to 0.99; nominal p=0.037).