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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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