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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 ]
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage.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.
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.
The selection and use of essential medicines: report of the WHO Expert Committee, 2017 (including the 20th WHO Model List of Essential Medicines and the 6th Model List of Essential Medicines for Children). Geneva: World Health Organization. hdl: 10665/259481. ISBN 978-92-4-121015-7. ISSN 0512-3054. WHO technical report series; no. 1006.
Suzetrigine is the first new painkiller approved in the US since Celebrex, a type of nonsteroidal anti-inflammatory drug called a Cox-2 inhibitor, which was approved in 1998.
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