Janssen’s Darzalex (daratumumab) Combination Therapy Receives FDA’s Approval for Frontline Multiple Myeloma

 Janssen’s Darzalex (daratumumab) Combination Therapy Receives FDA’s Approval for Frontline Multiple Myeloma

Janssen’s Darzalex (daratumumab) Combination Therapy Receives FDA’s Approval for Frontline Multiple Myeloma

Shots:

  • The approval is based on P-III CASSIOPEIA (MMY3006) study involve assessing of Darzalex + bortezomib, thalidomide and dexamethasone (VTd) vs VTd in 1,085 newly diagnosed patients with previously untreated symptomatic MM who are eligible for high dose CT and stem cell transplant
  • The P-III CASSIOPEIA study is sponsored by IFM in collaboration with HOVON and Janssen. Janssen has submitted the sBLA to the US FDA for this indication in Mar’2019 and has received PR with its expected PDUFA date as Sept 26, 2019
  • Darzalex is a mAb targeting CD38 molecule, being developed by Janssen under an exclusive WW license to develop, manufacture and commercialize daratumumab from Genmab and is being evaluated in P-III studies for a smoldering, relapsed and refractory and frontline MM

Click here to­ read full press release/ article | Ref: Genmab | Image: New Europe

Shiwani Sharma

Shiwani Sharma was Senior Editor 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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