Jan 22, 2020: The European Commission (EC) approved marketing authorisation for Janssen Pharmaceutical’s Darzalex (daratumumab) in combination with bortezomib, thalidomide and dexamethasone (VTd) for the treatment of multiple myeloma.
The approval, granted is based on the results of part one of the company’s Phase III CASSIOPEIA study, published in The Lancet.
The Phase III preliminary is a two-section study; section one exhibited that the total reaction rate was essentially higher in the daratumumab with VTd gathering, at 29 percent, contrasted with VTd alone, at 20 percent.
Movement free endurance (PFS) was altogether improved in the daratumumab-VTd set contrasted with exclusively VTd, the expansion of daratumumab to VTd brought about a 18-month PFS pace of 93 percent contrasted with 85 percent for VTd alone.
Most common side effects observed were: neutropenia, lymphopenia, stomatitis and thrombocytopenia. In the daratumumab-VTd blend arm, implantation related responses happened in 35 percent of patients. https://www.europeanpharmaceuticalreview.com/news/111080/ec-approves-darzalex-in-combination-with-vtd-for-multiple-myeloma/
