Oncologic Drugs Advisory Committee

Oncologic Drugs Advisory Committee
Committee Meeting on February 9, 2012 from 8:00 a.m. to 5:00 p.m. (Day 2 of 2)]

Agenda: On February 9, 2012, during the morning session, the committee will discuss supplemental new drug application (NDA) 21790/010 for DACOGEN (decitabine) for injection, application submitted by Eisai, Inc. The proposed indication (use) for this product is for the treatment of acute myelogenous leukemia (AML) in adults 65 years of age or older who are not considered candidates for induction chemotherapy, which is the standard first phase of treatment for AML.

During the afternoon session, the committee will discuss NDA 022481, with the proposed trade name PIXUVRI (pixantrone dimaleate) injection, application submitted by Cell Therapeutics, Inc. The proposed indication (use) for this product is as a single agent treatment for patients with relapsed or refractory (difficult to treat), aggressive Non-Hodgkin’s Lymphoma who received two or more prior lines of therapy.