Oncologic Drugs Advisory Committee

Oncologic Drugs Advisory Committee
Committee Meeting on April 12, 2011, from 8:00 a.m. to 5:00 p.m.

Agenda: On April 12, 2011, during the morning session, the committee will discuss supplemental new drug application (sNDA) 022334/S-009, trade name AFINITOR (everolimus) tablets, application submitted by Novartis Pharmaceuticals Corp. The proposed indication(use) for this product is for the treatment of patients with advanced neuroendocrine tumors (NET)of gastrointestinal, lung, or pancreatic origin.

During the afternoon session, the committee will discuss sNDA 021938/S-013, trade name SUTENT (sunitinib malate) capsules, application submitted by C.P. Pharmaceuticals International C.V., represented by Pfizer, Inc. (authorized U.S. agent). The proposed indication (use) for this product is for the treatment of unresectable pancreatic neuroendocrine tumors (PNET).