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[34] [35] In May 2016 daratumumab was also conditionally approved by the European Medicines Agency for treatment of multiple myeloma. [36] In November 2016, the FDA approved daratumumab in combination with lenalidomide or bortezomib and dexamethasone for the treatment of people with multiple myeloma who have received at least one prior therapy ...
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]
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage. See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page.
The FDA approved Nucala for the same indication in July 2021. This is the third indication for mepolizumab in China for an IL-5 mediated condition. It is estim. On Friday, the China National ...
Nucala, known also as mepolizumab, was first approved in 2015 for a type of severe asthma in the United States. Its sales grew 18% to 1.7 billion pounds in 2023. It contributed nearly 6% to GSK ...
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Mepolizumab was approved for medical use in the European Union in December 2015. [5] In September 2020, mepolizumab was approved in the United States to treat adults and children aged twelve years and older with hypereosinophilic syndrome (HES) for six months or longer without another identifiable non-blood related cause of the disease. [5]
In November 2022, GSK plc initiated the process for withdrawal of the United States marketing authorization for belantamab mafodotin following the request of the US FDA. [9] This request was based on the outcome of the DREAMM-3 phase III confirmatory trial, [10] which did not meet the requirements of the US FDA accelerated approval regulations ...