Oncologic Drugs Advisory Committee

During the morning session, the Committee will discuss new drug application (NDA) 208051, for neratinib maleate, an application submitted by Puma Biotechnology. The proposed indication is as a single agent for the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab-based therapy.

During the afternoon session, the Committee will discuss NDA 208587,for L-glutamine powder (oral solution), submitted by Emmaus Medical, Inc. The proposed indication is for the treatment of sickle cell disease.