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CLINICAL NEWS
Nelarabine and Standard Chemotherapy Improves Disease-Free Survival in Pediatric T-Cell Malignancies
Adding nelarabine to a standard chemotherapy regimen improved disease-free survival ( DFS ) in children and young adults with T-cell acute lymphocytic leukemia ( T- ALL ), compared with the chemotherapy regimen alone , according to results from the Children ’ s Oncology Group ( COG ) AALL0434 trial . With a four-year overall survival ( OS ) rate of 90 percent in the nelarabine-treated group , “ survival [ for this patient population ] is better than it has ever been ,” lead author Kimberly P . Dunsmore , MD , told ASH Clinical News .
Dr . Dunsmore , professor at Virginia Tech Carilion School of Medicine , presented the results from COGAALL0434 at the 2018 ASCO Annual Meeting . “[ This ] is the largest trial ever conducted for newly diagnosed T-ALL and T-cell lymphocytic lymphoma ( T-LLy ), showed outstanding overall outcomes , and [ nelarabine ] should become a new standard of care for [ T-ALL ],” she added .
The randomized , phase III trial enrolled 1,545 children
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FVIII plasma concentration
1000
FVIII levels through 48 hours ( N = 18 )
KOVALTRY ® Advate ®
FVIII IU / dL
100
10
KOVALTRY ®
10.0 IU / dL
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1
0 6 12 18 24 30 36 42 48
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Time , h Data are geometric means , based on chromogenic assay . |
Advate ®
4.5 IU / dL
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S : 9.75 ” |
T : 10 ” |
Compared to Advate ® , KOVALTRY ® demonstrated 2 : |
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% % % %
higher AUC 0-inf longer half-life lower clearance higher FVIII levels
SELECTED IMPORTANT SAFETY INFORMATION
Hemophilic patients with cardiovascular risk factors or diseases may be at the same risk to develop cardiovascular events as non-hemophilic patients when clotting has been normalized by treatment with Factor VIII .
Catheter-related infections may occur when KOVALTRY ® is administered via central venous access devices ( CVADs ). These infections have not been associated with the product itself .
The most frequently reported adverse reactions in clinical trials ( ≥3 %) were headache , pyrexia , and pruritus .
For additional risk and use information , please see Brief Summary on following pages .
You are encouraged to report negative side effects or quality complaints of prescription drugs to the FDA . Visit www . fda . gov / medwatch or call 1-800-FDA-1088 .
References : 1 . KOVALTRY ® [ prescribing information ]. Whippany , NJ : Bayer HealthCare LLC ; 2016 . 2 . Shah A , Solms A , Garmann D , et al . Improved pharmacokinetics with BAY 81-8973 versus antihemophilic factor ( recombinant ) plasma / albumin-free method : a randomized pharmacokinetic study in patients with severe hemophilia A [ Published online December 22 , 2016 ]. Clin Pharmacokinet . doi : 10.1007 / s40262-016-0492-2 . 3 . Data on file . Bayer HealthCare Pharmaceuticals , Inc ; 2016 .
Bayer , the Bayer Cross , and KOVALTRY are registered trademarks of Bayer . Advate is a registered trademark of Baxalta Incorporated , a wholly owned , indirect subsidiary of Shire plc . © 2017 Bayer . All rights reserved . Printed in USA 12 / 17 PP-675-US-1242