ODAC Recommends Approval of Gemtuzumab Ozogamicin for Newly-Diagnosed AML

July 11, 2017 – The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 6-1 in favor of approving gemtuzumab ozogamicin in combination with daunorubicin and cytarabine for the treatment of patients with newly-diagnosed CD33-positive acute myeloid leukemia (AML). The committee agreed that the anti-CD33 antibody conjugate … (leggi tutto)