Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee

Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee

November 30, 2010, from 8 a.m. to 5:30 p.m.

Agenda: On November 30, 2010, information will be presented regarding pediatric development plans for four products that were either recently approved by FDA or, are in late stage development for an adult oncology indication. 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) Crizotinib, manufactured by Pfizer, Inc.; (2) pralatrexate, manufactured by Allos Therapeutics, Inc.; (3) denosumab, manufactured by Amgen, Inc.; and (4) eribulin, manufactured by Eisai Inc.