Darzalex

Chemical Namedaratumumab
Dosage FormInjection (intravenous; 100 mg/5 mL, 400 mg/20 mL)
Drug ClassMonoclonal antibodies
SystemBlood
CompanyJanssen Biotech
Approval Year2015

Indication

  • 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.
  • For the treatment of adult patients with multiple myeloma in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant.
  • For the treatment of adult patients with multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant.
  • For the treatment of adult patients with multiple myeloma in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy.
  • For the treatment of adult patients with multiple myeloma in combination with pomalidomide and dexamethasone in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
  • For the treatment of adult patients with multiple myeloma 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.
Last updated on 10/8/2020

More on this drug: Clinical Trials

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Document TitleYearSource
Darzalex (daratumumab) Prescribing Information2019Janssen Biotech, Inc., Horsham, PA