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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 .
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This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage.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.
Genmab A/S announced on Jan. 15 that its drug, Darzalex Faspro has been approved by the US Food and Drug Administration (FDA) for the treatment of light-chain (AL) amyloidosis in adult patients ...
Amgen (AMGN) gets FDA nod for the label expansion of Kyprolis in combination with Darzalex Faspro and dexamethasone for treating patients with multiple myeloma at first or subsequent relapse.
The drug was given FDA priority review status in May. Sanofi plans to advance blood cancer drugs known as anti-CD38, which include Sarclisa, despite GenMab and Johnson & Johnson's strong foothold ...
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