Shots:

• The approval is based on P-Ib EQUULEUS (MMY1001) results assessing Darzalex in 240 patients with multiple myeloma and safety profile of Darzalex when administered single dose or split dose
• The split dosing regimen provides an option to health care practitioners to split the infusion of DARZALEX over two consecutive days and is approved by EC in Dec-2018 and its sBLA is filled by Janssen         
• Darzalex (daratumumab- IV infusion) is a human IgG1k mAb- binds with CD38 molecule targeted for multiple myeloma and has received two BT designation from the U.S. FDA for multiple myeloma- as both a monothx and combination therapy. In Aug 2012- Janssen acquired WW development & commercialization rights for Darzalex from Genmab  

Ref: Genmab | Image: Endpoints News