Astex and partner Janssen-Cilag International reported EC approval for Dacogen™ (decitabine) for the treatment of adults aged 65 years and over with newly diagnosed de novo or secondary acute myeloid leukemia (AML). The DNA hypomethylating drug is already approved for treating myelodysplastic syndromes (MDS) in over 35 countries, including the U.S.
EC clearance for the AML indication was based on results from the Phase III Dacoo-016 study, which compared treatment using either decitabine infusions, supportive care, or low-dose cytarabine in 485 subjects aged 65 years and over. An analysis of protocol-specified results showed that decitabine therapy was associated with a 54% increase in median overall survival (7.7 months for decitabine-treated patients, compared with 5.0 months in the comparator arm). Subsequent analysis of mature survival data confirmed the trend for overall survival and provided clinically significant evidence of decitabine efficacy.
“Dacogene nicely complements our growing portfolio of therapies to treat hematologic malignancies, which is one of our key areas of focus in oncology,” comments Peter Lebowitz, M.D., oncology therapeutic area head for Janssen R&D.
Astex Pharmaceuticals co-developed Dacogen and receives significant royalties on global sales from Eisai in North America and from Janssen-Cilag in the rest of the world. Under terms of its licensing deals the firm may receive up to $17.5 million in future payments if milestones are achieved for Dacogen globally.