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Daratumumab, sold under the brand name Darzalex among others, is an anti-cancer monoclonal antibody medication. It binds to CD38 , [ 7 ] which is overexpressed in multiple myeloma cells. [ 8 ]
It was approved for use in the United States in May 2020. [2] [7] [8]Efficacy of daratumumab and hyaluronidase-fihji (monotherapy) was evaluated in the COLUMBA trial (NCT03277105), an open-label non-inferiority trial randomizing 263 participants to daratumumab and hyaluronidase-fihj and 259 to intravenous daratumumab (daratumumab IV). [2]
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Created Date: 8/30/2012 4:52:52 PM
It is a tyrosine-kinase inhibitor and works by blocking a number of tyrosine kinases such as Bcr-Abl and the Src kinase family. [3] Dasatinib was approved for medical use in the United States and in the European Union in 2006. [3] [2] It is on the World Health Organization's List of Essential Medicines. [4]
m e m o r a n d u m department of health and human services public health service food and drug administration center for drug evaluation and research
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