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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Ref: Business wire  | Image: Janssen