Janssen’s Darzalex (daratumumab) Combination Regimen Receives EC’s Approval for Transplant Eligible Patients with Newly Diagnosed Multiple Myeloma

Shots:

• The approval is based on P-III CASSIOPEIA studyassessingDarzalex + bortezomib, thalidomide and dexamethasone (VTd) vs VTd in 1085 newly diagnosed patients with previously untreated, symptomatic MM, who were eligible for high-dose CT and stem cell transplant
• The P-III CASSIOPEIA study results: higher sCR (29% vs 20%); @18.8mos. improvement in PFS (93% vs 85%), published in The Lancet in Jun’2019 and at ASCO2019. The approval marks the sixth approval for Darzalex and the third in the frontline setting
• Darzalex is a CD38-directed antibody and is an approved therapy as monothx. or in combination with other drugs in multiple countries including the US for MM. In Aug’2012, Genmab granted exclusive rights of Darzalex to Janssen

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