February 10, 2010: Oncologic Drugs Advisory Committee Meeting...

February 10, 2010: Oncologic Drugs Advisory Committee Meeting Announcement

Center Date Time

CDER February 10, 2010
8:00 a.m. - 5:00 p.m.

Location

Hilton Washington DC North/Gaithersburg
The Ballrooms
620 Perry Parkway
Gaithersburg, Maryland

Agenda
On February 10, 2010, during the morning session, the committee will discuss new drug application (NDA) 022-481, proposed trade name PIXUVRI (pixantrone dimaleate) injection, manufactured by Cell Therapeutics, Inc. The proposed indication (use) for this product is as a single agent treatment for patients with recurring or refractory (difficult to treat), aggressive non-Hodgkins lymphoma (NHL) who have received two or more prior lines of therapy.

During the afternoon session, the committee will discuss NDA 022-374, proposed trade name OMAPRO (omacetaxine mepesuccinate) for injection, manufactured by ChemGenex Pharmaceuticals. The proposed indication (use) for this product is for the treatment of adults with chronic myeloid leukemia (CML) bearing a genetic alteration known as the Bcr-Abl T315I mutation, and who have failed prior therapy with the drug imatinib.