Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Eisai has received the US Food and Drug Administration's (FDA) acceptance to review its supplemental New Drug Application (sNDA) for Dacogen (decitabine) for injection as a treatment for acute myeloid leukemia (AML).
Subscribe to our email newsletter
The sNDA was submitted to the FDA on 6 May 2011 by Eisai.
The submission of the application was supported by the results of Phase III trial compared Dacogen versus treatment choice (TC) of either supportive care or low-dose cytarabine in older patients with newly diagnosed or secondary AML.
The study, which was an open-label, multi-center study involved around 485 patients.
SuperGen developed DACOGEN and receives royalties on global sales.