Pediatric Oncology Meeting Planned for 6/21-22

Federal Register notice: FDA has announced a 6/21-22 Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee meeting. On 6/21, information will be presented to gauge investigator interest in exploring potential pediatric development plans for three products in various stages of development for adult cancer indications. Products under consideration are: (1) Apexigen’s APX–005M; (2) PharmaMar USA’s PMO1183 (lurbinectedin); and (3) Astellas’ ASP2215 (gilteritinib). The subcommittee will consider and discuss issues concerning diseases to be studied, patient populations to be included, and possible study designs. On 6/22, 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. Products under consideration are: (1) Dista Products/Eli Lilly’s prexasertib; and (2) Eli Lilly’s olaratumab. To view the notice, click here.