Genmab’s Darzalex (daratumumab) + Bortezomib + Thalidomide and Dexamethasone (VTd) Receive FDA’s Priority Review to sBLA Filing for Frontline Multiple Myeloma

Genmab’s Darzalex (daratumumab) + Bortezomib + Thalidomide and Dexamethasone (VTd) Receive FDA’s Priority Review to sBLA Filing for Frontline Multiple Myeloma

Shots:

  • The sBLA is based on P-III CASSIOPEIA (MMY3006) study results assessing Darzalex + VTd in 1085 patients newly diagnosed with multiple myeloma, eligible for high -dose CT & autologous stem cell transplant
  • The P-III CASSIOPEIA study is sponsored by IFM in collaboration with HOVON & Janssen. The sBLA is submitted by Janssen in Mar’19 with its expected PDUFA date on Sept 26, 2019
  • Darzalex (IV) is an IgG1k mAb targeting CD38 molecule, developed & commercialized by Janssen under an exclusive WW license agreement with Genmab signed in Aug’12 and is available in the US, Europe & Japan

Click here to read full press release/ article | Ref: GlobeNewsWire | Image: Novameta