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Company Amgen Inc. / Boehringer Ingelheim Pharmaceuticals Inc. / Threshold Pharmaceuticals Inc. / Trametinib COMPANY / GlaxoSmithKline LLC / / Event FDA Phase / / IndustryTerm biological products / products / therapies for pediatric rare diseases / treatment of pediatric cancers / biologic products / / MedicalCondition BRAF V600-mutant melanoma / rare diseases / papillary thyroid cancer / differentiated thyroid cancer / Langerhans cell histiocytosis / myelodysplastic syndrome / metastatic soft tissue sarcomas / pediatric acute lymphoblastic leukemia / original rare disease / glioma / V600-mutant metastatic melanoma / neuroblastoma / rare pediatric disease / melanoma / non-small cell lung cancer / juvenile pilocytic astrocytoma / pediatric rare disease / recurrent solid tumors / pediatric rare diseases / pancreatic cancer / specific diseases / cancer / neuroblastoma and neurofibromatosis-related tumors / tumors / disease / malignant peripheral nerve sheath tumors / pediatric melanoma / recurrent/refractory cancer / rare disease / myeloid leukemias / soft tissue sarcoma / optic glioma / Therefore pediatric tumors / triple negative breast cancer / sarcomas / pediatric cancers / several pediatric cancers / several other adult tumor / pediatric gliomas / metastatic melanoma / / Organization office of Hematology and Oncology Products / Food and Drug Administration / Congress / Review Committee / Review Division / DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring / Oncologic Drugs Advisory Committee / FDA Briefing Document Pediatric Oncology Subcommittee / Advisory Committee / Pediatric Oncology Subcommittee / / Person Silver Spring / Richard Pazdur / / Position investigator / Director / / Product CR-406 / Act / V600 / / ProvinceOrState Maryland / / Technology simulation / drug development / / URL http / SocialTag 
Microsoft Word - FINAL 2012 Peds ODAC briefing document[removed]doc