Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee

Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee,
November 1, 2011, from 8 a.m. to 5:30 p.m.]

Agenda: On November 1, 2011, information will be presented regarding pediatric development plans for four products that were either recently approved by FDA, are in late stage development for an adult oncology indication, or in late stage development in pediatric patients with cancer. The subcommittee will consider and discuss issues relating to the development of each product for pediatric use and provide guidance to facilitate the formulation of Written Requests for pediatric studies, if appropriate. The four products under consideration are: (1) Sodium thiosulfate injection, application submitted by Adherex Technologies, Inc.; (2) vismodegib (GDC–0449), application submitted by Genentech, Inc.; (3) pazopanib, application submitted by Glaxo Wellcome Manufacturing Pte Ltd., Singapore doing business as GlaxoSmithKline; and (4) Medi-573 (fully human antibody to IGF–I and IGF–II), application submitted by MedImmune, LLC.