What Is DARZALEX® and How Does It Work?

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A new option for patients with multiple myeloma: DARZALEX® can now be used in combination with Revlimid® (lenalidomide) and dexamethasone or Velcade® (bortezomib) and dexamethasone in patients who have received at least one prior medicine.

How does DARZALEX® work?
  • DARZALEX® is not chemotherapy. DARZALEX® is a monoclonal antibody that works with your immune system. Monoclonal antibodies work by attaching themselves to multiple myeloma cells in your body and directly killing them, and/or signaling your immune system to destroy them
  • DARZALEX® finds and attaches to a protein called CD38, which is present on the surface of cells, including high numbers on myeloma cells
RESULTS SEEN IN CLINICAL TRIALS
  • The main goal of the study was to measure the length of time patients live without their multiple myeloma getting worse or their passing away from any cause
    • Another goal was to measure response rate, which is the percentage of patients who responded to treatment. Talk to your doctor about how response is measured
  • The majority of patients responded to the following DARZALEX® combination treatments:
    • ​DARZALEX® was studied in combination with Revlimid® and dexamethasone (Rd) vs Rd alone in 569 patients who had received a minimum of 1 prior treatment
      • 9 out of 10 patients responded to DARZALEX® + Rd vs 7 out of 10 with Rd alone
    • DARZALEX® was studied in combination with Velcade® and dexamethasone (Vd) vs Vd alone in 498 patients who had received a minimum of 1 prior treatment
      • Almost 8 out of 10 patients responded to DARZALEX® + Vd vs almost 6 out of 10 with Vd alone
  • DARZALEX® combination treatments reduced patients’ risk of their disease getting worse or their passing away from any cause by more than 60%

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Revlimid® is a registered trademark of Celgene Corporation.
Velcade® is a registered trademark of Millennium Pharmaceuticals, Inc.

What Is DARZALEX®?

DARZALEX® is a prescription medicine used to treat a type of cancer called multiple myeloma in people who:

  • Have received at least 3 prior medicines to treat multiple myeloma, including a proteasome inhibitor (PI) and an immunomodulatory agent, or
  • Did not respond to a (PI) and an immunomodulatory agent

It is not known if DARZALEX® is safe and effective in children.

DARZALEX® is approved based on response. Clinical trials are still ongoing.
     
DARZALEX® belongs to a group of medicines called monoclonal antibodies. DARZALEX® is the first monoclonal antibody approved for treating multiple myeloma. Your doctor may begin treatment with DARZALEX® if you: 

  • Have received at least 3 prior medicines to treat multiple myeloma, including a PI such as Velcade®(bortezomib) and an immunomodulatory agent such as Revlimid® (lenalidomide), or  
  • Did not respond to a PI and an immunomodulatory agent
 

How Does DARZALEX® Work?

What is DARZALEX® (daratumumab) and how does it work?

DARZALEX® is a monoclonal antibody that works with your immune system. One way monoclonal antibodies work is by attaching themselves to multiple myeloma cells in your body and directly killing them, and/or signaling your immune system to destroy them.

DARZALEX® finds and attaches to a protein called CD38, which is present on the surface of cells, including high numbers on myeloma cells.

Once DARZALEX® attaches to the CD38 protein, it works in many ways, by helping your immune system find and kill myeloma cells and/or by killing the myeloma cells on its own.

 

 

How Was DARZALEX® Studied?

The efficacy and safety of DARZALEX® were studied in a trial of 106 people with multiple myeloma who either:

  • Had received at least 3 prior treatments, including a PI and an immunomodulatory agent, or
  • After receiving both a PI  and an immunomodulatory agent, had not gotten better or had gotten better but worsened

Patients in the study had actually received a median of 5 prior treatments.

In this trial, DARZALEX® was given as a monotherapy, which means that it was given alone, not in combination with other multiple myeloma treatments.

 

DARZALEX® is the first monoclonal antibody approved for people with this type of cancer.

    Velcade® is a registered trademark of Millennium Pharmaceuticals, Inc. Revlimid® is a registered trademark of Celgene Corporation.