BioCentury
ARTICLE | Clinical News

Dacogen decitabine regulatory update

February 18, 2013 8:00 AM UTC

Last December, the U.K.'s NICE terminated an appraisal of Dacogen decitabine to treat acute myelogenous leukemia (AML) because Johnson & Johnson declined to make a submission to the agency. The hypomethylating agent is approved in Europe to treat newly diagnosed de novo or secondary AML in patients aged >=65 years. In January, the Scottish Medicines Consortium recommended against the use of Dacogen for the approved indication because it also did not receive a submission. The drug has Orphan Drug status in the EU for AML (see BioCentury, Jan. 21). ...