Data from CASTOR Phase III trial published in New England Journal of Medicine
In July of this year, daratumumab was granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA).
The Phase III CASTOR study, which involved 498 patients with relapsed or refractory multiple myeloma, achieved its primary goal of increasing progression free survival (PFS).
“We are pleased that the positive data from the Phase III CASTOR study of daratumumab, which was presented earlier this year at the ASCO and EHA meetings, has now been published in the prestigious New England Journal of Medicine,” Genmab CEO Jan van de Winkel said. “The data from this study formed part of the basis of this month’s submission of the supplemental Biologics License Application to the U.S. Food and Drug Administration and the submission of the variation to the Marketing Authorization to the European Medicines Agency.”