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

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

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  • 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

Ref: GlobeNewsWire | Image: Novameta

Click here to­ read the full press release 

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This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

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