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