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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]
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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In combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant ...
Mepolizumab, sold under the brand name Nucala by GlaxoSmithKline, is a humanized monoclonal antibody used for the treatment of severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis, and hypereosinophilic syndrome (HES). [5] It recognizes and blocks interleukin-5 (IL-5), a signalling protein of the immune system.
The US Food and Drug Administration (FDA) granted the application for belantamab mafodotin priority review, orphan drug, and breakthrough therapy designations. [ 5 ] In 2023, the confirmatory phase III DREAMM-3 trial aimed to compare belantamab mafodotin versus pomalidomide plus low-dose dexamethasone in participants with relapsed or refractory ...