Shots:

• The approval is based on P-III ALCYONE study results assessing Darzalex + VMP (bortezomib- melphalan and prednisone) vs VMP as monothx. in 706 newly diagnosed patients with multiple myeloma who are ineligible for autologous stem cell transplant
• The P-III ALCYONE study resulted in 50% reduction in PFS. In Aug’2012 Genmab granted Janssen exclusive WW rights to develop- manufacture and commercialize Darzalex and will receive ~$7M as a milestone from Janssen
• 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 the treatment of multiple myeloma and has received two US FDA’s BT designation for certain indications of MM- including as a monothx. for heavily pretreated MM and in combination with other therapies for 2L MM

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Ref: Genmab | Image: Janssen