Darzalex Approval History
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 binds with high affinity to the transmembrane ectoenzyme CD38 on the surface of multiple myeloma cells. It works by inducing rapid tumor cell death.
Darzalex is administered via intravenous infusion. Patients are given antihistamine, antipyretic, and corticosteroid medicines before each dose, and corticosteroids after each dose to reduce the risk of infusion reactions.
Darzalex may cause serious reactions, including infusion reactions. The most common side effects reported in clinical studies were fatigue, nausea, back pain, pyrexia, cough, and upper respiratory tract infection.
Development History and FDA Approval Process for Darzalex
|Feb 12, 2019|| FDA Approves Darzalex (daratumumab) Split-Dosing Regimen|
|May 7, 2018|| Janssen Announces Darzalex (daratumumab) U.S. FDA Approval for Newly Diagnosed Patients with Multiple Myeloma who are Transplant Ineligible|
|Jun 16, 2017|| Genmab Announces U.S. FDA Approval of Darzalex (daratumumab) in Combination with Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma|
|Nov 21, 2016|| Darzalex (daratumumab) Approved by FDA 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|| 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|
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