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Daratumumab was originally developed by Genmab, but it is now being jointly developed by Genmab along with the Johnson & Johnson subsidiary Janssen Biotech, which acquired worldwide commercialization rights to the drug from Genmab. [9] Daratumumab was granted breakthrough therapy drug status in 2013, for multiple myeloma.
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]
cryopyrin-associated periodic syndrome, Yao's Syndrome, Adult Onset Still's Disease: Cantuzumab mertansine [42] mab: humanized: CanAg (a glycoform of MUC1) colorectal cancer etc. Cantuzumab ravtansine [42] mab: humanized: CanAg (a glycoform of MUC1) cancers Caplacizumab [44] Cablivi: sdAb: humanized: VWF: Y: thrombotic thrombocytopenic purpura ...
Ofatumumab (Kesimpta 20 mg solution for injection in pre-filled syringe/pen) is indicated for the treatment of relapsing forms of multiple sclerosis in adults. [9] [11] [16] The recommended dose is 20 mg of ofatumumab administered by subcutaneous injection with monthly dosing following loading.
Trastuzumab deruxtecan is indicated for the treatment of adults with unresectable (unable to be removed with surgery) or metastatic (when cancer cells spread to other parts of the body) HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting and for adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal ...
Previously considered a promising drug, the FDA granted olaratumab fast track designation, breakthrough therapy designation and priority review status. In October 2016, the US FDA issued an accelerated approval notice for use of olaratumab with doxorubicin to treat adults with certain types of soft-tissue sarcoma, based on the same study.
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