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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]
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 ]
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.
Genmab A/S is a Danish biotechnology company, founded in February 1999 by Florian Schönharting, at the time managing director of BankInvest Biomedical venture fund. [7] The company is based in Copenhagen, Denmark – internationally, it operates through the subsidiaries Genmab B.V. in Utrecht, the Netherlands, Genmab U.S., Inc. in Princeton, New Jersey, US, and Genmab K.K. in Tokyo, Japan.
COPENHAGEN, Denmark; January 22, 2025 – Genmab A/S (Nasdaq: GMAB) announced today that worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO ® in the U.S.), as reported by J&J were USD 11,670 million in 2024.
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