Oncologic Drugs Advisory Committee

Oncologic Drugs Advisory Committee
Meeting on December 7, 2011, from 8 a.m. to 5 p.m.

Agenda: On December 7, 2011, during the morning session, the committee will discuss new drug application (NDA) 202324, with the proposed trade name Inlyta (axitinib) tablets, application submitted by Pfizer, Inc. The proposed indication (use) for this product is for the treatment of patients with advanced renal cell carcinoma (kidney cancer). During the afternoon session, the committee will discuss new drug application (NDA) 202799, with the established name peginesatide injection, application submitted by Affymax, Inc. The proposed indication (use) for this product is for the treatment of anemia associated with chronic renal failure in adult patients on dialysis.