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and nausea ( 38 %), and the most common grade 3 / 4 AEs were thrombocytopenia ( 29 %), anemia ( 15 %), and neutropenia ( 14 %). Serious AEs ( occurring in ≥2 patients ) included pneumonia ( n = 5 ), sepsis ( n = 3 ), pyrexia ( n = 3 ), influenza ( n = 3 ), febrile neutropenia ( n = 3 ), thrombocytopenia ( n = 2 ), cardiac failure ( n = 2 ), lower respiratory tract infection ( n = 2 ), |
acute kidney injury ( n = 2 ), respiratory failure ( n = 2 ), embolism ( n = 2 ), and hypotension ( n = 2 ).
The maximum tolerated dose ( primary endpoint ) of venetoclax was not determined ; the researchers selected 800 mg as the recommended phase II dose because “ overall response and very good partial response or better ( ≥VGPR ) response rates
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increased with increasing venetoclax dose through 800 mg across all patients .”
Forty-four patients ( 67 %) responded to treatment , with a median response duration of 9.7 months ( range = 7.4-15.8 months ). Twenty-eight patients ( 42 %) achieved ≥VGPR , including three stringent complete responses ( CRs ), 10 CRs , and 15 VGPRs . Six
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patients ( 9 %) had stable disease and 14 experienced disease progression as best response .
Response rates were greatest in patients who were not refractory to previous bortezomib treatment and had received one to three prior lines of therapy ( overall response rate = 97 %; ≥VGPR = 73 %), compared with patients who were refractory to prior bortezomib or
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IMPORTANT SAFETY INFORMATION , continued
Hypersensitivity Reactions Serious or fatal hypersensitivity reactions , including anaphylactic reactions , have been reported with daunorubicin and cytarabine . Monitor patients for hypersensitivity reactions . If a mild or moderate hypersensitivity reaction occurs , interrupt or slow the rate of infusion with VYXEOS and manage symptoms . If a severe or life-threatening hypersensitivity reaction occurs , discontinue VYXEOS permanently , treat the symptoms , and monitor until symptoms resolve .
Copper Overload VYXEOS contains copper . Monitor total serum copper , serum non-ceruloplasmin-bound copper , 24-hour urine copper levels , and serial neuropsychological examinations during VYXEOS treatment in patients with Wilson ’ s disease or other copper-related metabolic disorders . Use only if the benefits outweigh the risks . Discontinue in patients with signs or symptoms of acute copper toxicity .
Tissue Necrosis Daunorubicin has been associated with severe local tissue necrosis at the site of drug extravasation . Administer VYXEOS by the intravenous route only . Do not administer by intramuscular or subcutaneous route .
Safety and effectiveness of VYXEOS in pediatric patients have not been established .
Embryo-Fetal Toxicity VYXEOS can cause embryo-fetal harm when administered to a pregnant woman . Patients should avoid becoming pregnant while taking VYXEOS . Advise females and males of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of VYXEOS .
MOST COMMON ADVERSE REACTIONS
The most common adverse reactions ( incidence ≥25 %) were hemorrhagic events , febrile neutropenia , rash , edema , nausea , mucositis , diarrhea , constipation , musculoskeletal pain , fatigue , abdominal pain , dyspnea , headache , cough , decreased appetite , arrhythmia , pneumonia , bacteremia , chills , sleep disorders , and vomiting .
Please see following pages for Brief Summary of full Prescribing Information , including BOXED Warning .
Reference : 1 . VYXEOS [ package insert ]. Palo Alto , CA : Jazz Pharmaceuticals . a
Cytarabine and daunorubicin .
AML = acute myeloid leukemia ; AML-MRC = acute myeloid leukemia with myelodysplasia-related changes ; HR = hazard ratio ; MDS = myelodysplastic syndromes ; t-AML = therapy-related acute myeloid leukemia .
© 2017 Jazz Pharmaceuticals VYX-0036 ( 1 ) a Rev0817