The US FDA has posted details, including company and FDA Briefing Materials, for the Tuesday to Wednesday, June 28-29, 2016 meeting of the Pediatric Oncologic Subcommittee of the Oncologic Drugs Advisory Committee (ODAC). The Subcommittee will consider information pertinent to the formulation of pediatric studies for the following 5 products: (1) VENETOCLAX by AbbVie, Inc.; (2) TAZEMETOSTAT by Epizyme, Inc.; (3) ATEZOLIZUMAB by Roche/Genentech; (4) LOXO-101 by Loxo Oncology, Inc.; and (5) ENTRECTINIB sponsored by Ignyta, Inc. In addition, the FDA will seek input in regard to approaches to treat diffuse intrinsic pontine glioma (DIPG).
See the SAC Tracker report