Shots:

• The approval is based on P-III CASSIOPEIA (MMY3006) study involve assessing of Darzalex + bortezomib- thalidomide and dexamethasone (VTd) vs VTd in 1-085 newly diagnosed patients with previously untreated symptomatic MM who are eligible for high dose CT and stem cell transplant
• The P-III CASSIOPEIA study is sponsored by IFM in collaboration with HOVON and Janssen. Janssen has submitted the sBLA to the US FDA for this indication in Mar’2019 and has received PR with its expected PDUFA date as Sept 26- 2019
• Darzalex is a mAb targeting CD38 molecule- being developed by Janssen under an exclusive WW license to develop- manufacture and commercialize daratumumab from Genmab and is being evaluated in P-III studies for a smoldering- relapsed and refractory and frontline MM

Click here to­ read full press release/ article 

Ref: Genmab | Image: Janssen