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Darzalex Approval History

  • FDA approved: Yes (First approved November 16th, 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 combination treatment of patients with multiple myeloma who have received at one three prior therapy.

FDA Approval: The safety and efficacy of Darzalex were demonstrated in two open-label studies. In the Phase 2 MMY2002 (SIRIUS) study, of the 106 participants receiving Darzalex, 29 percent of patients experienced a complete or partial reduction in their tumor burden, which lasted for an average of 7.4 months. In the Phase 1/2 GEN501 study, of the 42 participants receiving Darzalex, 36 percent had a complete or partial reduction in their tumor burden.

Mechanism: Darzalex is a human monoclonal antibody (mAb) that binds with high affinity to the transmembrane ectoenzyme, CD38, on the surface of multiple myeloma cells. It works by inducing rapid tumor cell death.

Administration: Darzalex is administered via intravenous infusion which should be completed within 15 hours. It is usually given every week for the first 8 weeks, then every two weeks for 16 weeks, and then every 4 weeks thereafter until the disease progresses. Patients will receive antihistamine, antipyretic, and corticosteroid medicines an hour before each dose, and corticosteroids for the first two days after each dose to reduce the risk of infusion reactions.

Side Effects: The most frequently reported adverse reactions in clinical studies were fatigue, nausea, back pain, pyrexia, cough, upper respiratory tract infection, and infusion-related reactions. Common symptoms of infusion-related reactions include nasal congestion, chills, cough, allergic rhinitis, throat irritation, dyspnea and nausea.

Additional Information: Darzalex may cause serious reactions, including infusion reactions, and may interfere with certain blood tests. Pregnant women should not use Darzalex, and women planning to become pregnant should use effective contraceptives during, and for at least three months after treatment.

Development History and FDA Approval Process for Darzalex

Nov 21, 2016Approval 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, 2015Approval FDA 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

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