Janssen’s Darzalex (daratumumab) Combination Regimen Receives CHMP’s Positive Opinion for Transplant Eligible Patients with Newly Diagnosed Multiple Myeloma

Shots:

• The CHMP positive opinion is based on P-III CASSIOPEIA (MMY3006) study assessing the combination of Darzalex + bortezomib, thalidomide and dexamethasone vs bortezomib, thalidomide and dexamethasone alone in 1,085 newly diagnosed patients with previously untreated symptomatic MM, eligible for ASCT
• If approved, the combination regimen will be the first Darzalex based regimen that would be a potential treatment option for newly diagnosed patients with MM who are eligible for ASCT in the EU
• 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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