Genmab’s Darzalex (daratumumab) Split Dosing Regimen Receives the US FDA Approval for Multiple Myeloma

 Genmab’s Darzalex (daratumumab) Split Dosing Regimen Receives the US FDA Approval for Multiple Myeloma

Genmab’s Darzalex (daratumumab) Split Dosing Regimen Receives the US FDA Approval for Multiple Myeloma

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  

Click here to read full press release/ article | Ref: Genmab | Image: Endpoints News


Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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