BioCentury
ARTICLE | Clinical News

Dacogen decitabine regulatory update

March 12, 2012 7:00 AM UTC

FDA issued a complete response letter for an sNDA from Eisai for Dacogen decitabine to treat acute myelogenous leukemia (AML) in patients 65 years and older. According to Eisai and partner Astex, FDA declined to approve the application because Dacogen did not demonstrate a statistically significant improvement in overall survival (OS) over low-dose cytarabine or supportive care in the Phase III DACO-016 trial (p=0.11). Details of the letter were not disclosed. Eisai is determining next steps. In February, FDA's Oncologic Drugs Advisory Committee voted 10-3, with 1 abstention, that Dacogen did not demonstrate a favorable benefit-risk profile in the indication (see BioCentury, Feb. 13). ...