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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 phase III demonstrated the superiority of bortezomib over a high-dose dexamethasone regimen (e.g. median TTP 6.2 vs 3.5 months, and 1-year survival 80% vs 66%). [7] New studies show that bortezomib may potentially help recover from vincristine treatment in treating acute lymphoblastic leukemia, when replacing vincristine in the process.
The trial assessed Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BVd) versus Johnson & Johnson’s (NYSE:JNJ) Darzalex (daratumumab) in combination with ...
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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 ...
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