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Daratumumab, sold under the brand name Darzalex among others, is an anti-cancer monoclonal antibody medication. It binds to CD38 , [ 7 ] which is overexpressed in multiple myeloma cells. [ 8 ]
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]
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 ...
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage.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.
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.
Approved medications for the condition include J&J's Darzalex and generic cancer drugs such as pomalidomide and bortezomib. CAR-T therapies have recently come under scrutiny from health regulators ...
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