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Darzalex FDA Approval History

Reviewed by J.Stewart BPharm. Last updated on Sep 30, 2019.

FDA Approved: Yes (First approved November 16, 2015)
Brand name: Darzalex
Generic name: daratumumab
Dosage form: Injection
Company: Janssen Biotech, Inc.
Treatment for: Multiple Myeloma

Darzalex (daratumumab) is a human anti-CD38 monoclonal antibody indicated for the treatment of patients with multiple myeloma.

Darzalex is indicated for the treatment of adult patients with multiple myeloma:

  • in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy
  • in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant
  • in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant
  • in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy
  • in combination with pomalidomide and dexamethasone in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor
  • as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.

Development Timeline for Darzalex

DateArticle
Aug 20, 2020ApprovalFDA Approves New Kyprolis (carfilzomib) Combination Regimen with Darzalex (daratumumab) and Dexamethasone in Both Once- And Twice-Weekly Dosing Regimens
May  2, 2020ApprovalFDA Approves Darzalex¬†Faspro (daratumumab and hyaluronidase-fihj) for the Treatment of Patients with Multiple Myeloma
Sep 26, 2019ApprovalFDA Approves Darzalex (daratumumab) Combination Regimen for Newly Diagnosed, Transplant-Eligible Patients with Multiple Myeloma
Jun 27, 2019ApprovalFDA Approves Darzalex (daratumumab) in Combination with Lenalidomide and Dexamethasone for Newly Diagnosed Patients with Multiple Myeloma Who Are Transplant Ineligible
Feb 12, 2019ApprovalFDA Approves Darzalex (daratumumab) Split-Dosing Regimen
May  7, 2018ApprovalFDA Approves Darzalex (daratumumab) for Newly Diagnosed Patients with Multiple Myeloma who are Transplant Ineligible
Jun 16, 2017ApprovalFDA Approves Darzalex (daratumumab) in Combination with Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma
Nov 21, 2016ApprovalFDA Approves Darzalex (daratumumab) in Combination with Two Standard of Care Regimens for the Treatment of Patients with Multiple Myeloma Who Have Received At Least One Prior Therapy
Nov 16, 2015ApprovalFDA Approves Darzalex (daratumumab) for Patients with Previously Treated Multiple Myeloma
Sep  4, 2015U.S. FDA Grants Priority Review to Janssen for Daratumumab as a Treatment for Multiple Myeloma
Jun  5, 2015Janssen Initiates Rolling Submission of BLA for Daratumumab for the Treatment of Multiple Myeloma
Feb  3, 2015Genmab Announces Preliminary Results in Phase II Study of Daratumumab in Double Refractory Multiple Myeloma
May  1, 2013Daratumumab Receives Breakthrough Therapy Designation in Double Refractory Multiple Myeloma from U.S. FDA
Aug 30, 2012Janssen Biotech Announces Global License and Development Agreement for Investigational Anti-Cancer Agent Daratumumab

Further information

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