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Daratumumab was given priority review status by the US Food and Drug Administration (FDA) for multiple myeloma as a combination therapy (second line). [24] Daratumumab phase III trials for multiple myeloma show great promise in combination therapy with lenalidomide and dexamethasone, [32] as well as with bortezomib and dexamethasone. [33 ...
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 most widely used regiment, and first line therapy, for those ineligible for a stem cell transplant is cyclophosphamide, bortezomib and dexamethasone (CyBorD) with daratumumab added. [4] Daratumumab, a monoclonal antibody to CD38, a protein that is expressed on plasma cells, was approved in US and EU for AL Amyloidosis in 2021.
[113] The addition of subcutaneous daratumumab to induction and consolidation therapy with bortezomib, lenalidomide, and dexamethasone, and to lenalidomide maintenance therapy, conferred improved progression-free survival among transplantation-eligible patients with newly diagnosed multiple myeloma. [114]
Velcade is the first oncology drug marketed and promoted by Millennium. Velcade was granted FDA approval little more than four and a half years after initiation of the first clinical trial. To discover and develop such treatments, the Company focuses on key molecular pathways that play crucial roles in underlying disease processes, and on ...
Bortezomib, sold under the brand name Velcade among others, is an anti-cancer medication used to treat multiple myeloma and mantle cell lymphoma. [4] This includes multiple myeloma in those who have and have not previously received treatment. [3] It is generally used together with other medications. [3] It is given by injection. [4]
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