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Pediatric Oncology Subcommittee to Meet

06/16/2016

Federal Register Notice: FDA will hold a meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee6/28 from 8 a.m. to 3:15 p.m. and 6/29, from 8 a.m. to 4:15 p.m. at FDA’s White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. On 6/28 information will be presented to gauge investigator interest in exploring potential pediatric development plans for four products in various stages of development for adult cancer indications. The products under consideration are AbbVie’s Venetoclax, Epizyme’s Tazemetostat, Roche/Genentech’s Atezolizumab. On 6/29 during the morning session, information will be presented to gauge investigator interest in exploring potential pediatric development plans for two products in various stages of development for adult cancer indications: Loxo Oncology’s Loxo-101 and Ignyta’s Entrectinib. During the afternoon session, information will be presented on the current unmet clinical need in the nearly uniformly fatal brain tumor, diffuse intrinsic pontine glioma, which occurs predominantly in the pediatric age group. Contact Lauren D. Tesh, (301) 796-9001. To view this notice, click here. To view this notice, click here.

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