CLINICAL NEWS |
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support an indication of maintenance therapy ,” she said . “ Patients were not prerandomized before the start of maintenance therapy , making it impossible to determine in a rigorous way whether midostaurin administered as maintenance therapy contributed to the overall treatment effect and the survival benefit observed in the study .” She noted , though , that the labeling for midostaurin includes information about the maintenance-therapy dosing used in the |
pivotal trial as a reference for physicians .
Though midostaurin 50 mg twice-daily appeared to have a favorable safety profile , Dr . Ward noted certain limitations of the safety reporting in the RATIFY trial . Grade 1 / 2 AEs were not captured , except for 13 prespecified AEs : neutrophils / granulocytes , platelets , hemoglobin , febrile neutropenia , diarrhea , nausea , vomiting , ataxia , fatigue , rash / desquamation , mucositis / stomatitis , keratitis , and left ventricular systolic
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dysfunction . The most common AEs ( ≥20 %) were febrile neutropenia , nausea , mucositis , vomiting , headache , petechiae , musculoskeletal pain , epistaxis , devicerelated infection , hyperglycemia , and upper respiratory tract infection .
“ The seriousness of AEs was not captured by investigators … and several events common to [ patients with ] AML were exempt from investigational new drug application safety reporting ,” she
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said . “ However , the randomized study design allowed us to draw broad conclusions about the safety of midostaurin [ in this setting ].”
Laura C . Michaelis , MD , of the Medical College of Wisconsin Cancer Center in Milwaukee , offered a clinician ’ s perspective on using midostaurin , highlighting concerns about the risk of fungal infections during the long induction period . “ The label for this drug includes
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