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Saturday, May 02, 2020 2:46:36 AM
Press release from Genmab(GMAB):
“The approval of the subcutaneous formulation of daratumumab, DARZALEX FASPRO, is a landmark event in the development of daratumumab. Not only is it now the first and only subcutaneous CD38 antibody approved for the treatment of multiple myeloma, the subcutaneous administration of DARZALEX FASPRO considerably reduces treatment burden, as the fixed-dose injection is administered in approximately three to five minutes, offering patients a more convenient treatment experience. As seen in the pivotal study supporting the approval, this reduction in infusion time from hours to minutes led to higher satisfaction levels for patients and in addition, infusion-related reactions were both mild and significantly reduced with this formulation of daratumumab. We are very much looking forward to the launch of DARZALEX FASPRO in the U.S. and the potential for positive impact it will have on the lives of the patients receiving the drug,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
https://ir.genmab.com/news-releases/news-release-details/genmab-announces-us-fda-approval-subcutaneous-formulation
"As seen in the pivotal study supporting the approval, this reduction in infusion time from hours to minutes led to higher satisfaction levels for patients and in addition, infusion-related reactions were both mild and significantly reduced with this formulation of daratumumab."
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