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Immunosuppressants / Orphan drugs / Hematologic neoplasms / Bortezomib / Pyrazines / Lenalidomide / Panobinostat / Carfilzomib / Histone deacetylase inhibitor / Medicine / Chemistry / Organic chemistry


FDA ONCOLOGIC DRUGS ADVISORY COMMITTEE BRIEFING DOCUMENT Panobinostat capsules ODAC Meeting Date: 6 November 2014
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Company

abbreviations AE / AEs / Novartis / Cancer Therapy/Gynecologic Oncology Group / /

Country

United States / /

Event

FDA Phase / /

IndustryTerm

treatment / Cancer Therapy / Treatment of Cancer / /

MedicalCondition

cancers / refractory disease / cell transplant bortezomib confidence interval chronic myeloid leukemia / Pneumonia / Cancer / multiple myeloma / tumors / disease / important cancer / marrow dysfunction / recurrent infections / refractory multiple myeloma / cutaneous T-cell lymphoma deacetylase dexamethasone dose-limiting toxicity duration / Neutropenia / Ischemic heart disease / hematologic malignancies / Thrombocytopenia / relapsed and refractory disease / peripheral neuropathy / bone disease / pain / refractory multiple myeloma Multiple myeloma / Diarrhea / Severe infections / infection / renal failure / NDA adverse event acute myeloid leukemia / Renal dysfunction / multiple myeloma minimal response minimal response rate maximum / Anemia / sepsis / /

MedicalTreatment

salvage therapy / chemotherapy / /

Organization

Food and Drug Administration / European Society for Blood and Marrow Transplantation / Independent Data Monitoring Committee / European Organisation for Research and Treatment of Cancer Functional Assessment / FDA / /

Position

investigator / LBH589/panobinostat Executive / Executive / General / /

Product

dexamethasone / FDA ONCOLOGIC DRUGS ADVISORY COMMITTEE BRIEFING DOCUMENT Panobinostat capsules / B2207 / C30 / DUS71 / US / United States / D2308 / /

Technology

pharmacokinetics / gene expression / chemotherapy / Transplantation / pharmacodynamics / apoptosis / /

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