What Is DARZALEX® and How Does It Work?

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What Is DARZALEX®?

DARZALEX® is a treatment used to treat a type of cancer called multiple myeloma. Depending on where you are in your treatment journey, your doctor may discuss treatment with DARZALEX® as:

  • part of a combination therapy in combination with Revlimid® (lenalidomide) and dexamethasone or Velcade® (bortezomib) and dexamethasone if you have received at least 1 prior medicine
  • a monotherapy if you have received at least 3 prior medicines, including an immunomodulatory agent, such as Revlimid®, and a proteasome inhibitor (PI), such as Velcade®, or if you 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 CD38-Targeted Monoclonal Antibody

DARZALEX® is not chemotherapy. DARZALEX® is a monoclonal antibody that works in several ways. One way this monoclonal antibody works is by attaching itself to multiple myeloma cells in your body and directly killing them, and/or allowing your immune system to destroy them.

DARZALEX® targets and attaches to a protein called CD38, which is present on the surface of certain types of cells (eg, red blood cells) and is also present in high numbers on multiple myeloma cells. Since DARZALEX® targets the CD38 protein, it may also affect other cells with this protein on their surface.

 

 

How Was DARZALEX® Studied?

DARZALEX®  studied in combination with Revlimid®  + dexamethasone

DARZALEX®  was studied in combination with Revlimid®  + dexamethasone (Rd) vs Rd alone in 569 patients who had received a minimum of 1 prior medicine for their multiple myeloma. The main goal of the study was to measure the length of time patients lived without their multiple myeloma getting worse or their passing away from any cause. Another goal was to measure overall response rate, which is the percentage of patients who responded to treatment. Talk to your doctor about how response is measured.

Clinical trial results: DARZALEX® + Rd vs Rd alone

DARZALEX® in combination with Rd increased the time patients lived without their multiple myeloma getting worse or their passing away from any cause.

  • 63% less risk of disease progression or passing away with DARZALEX® in combination with Rd vs Rd alone

More patients responded to DARZALEX® in combination with Rd vs Rd alone

 

DARZALEX®  studied in combination with Velcade®  + dexamethasone

DARZALEX® was studied in combination with Velcade® + dexamethasone (Vd) vs Vd alone in 498 patients who had received a minimum of 1 prior medicine for their multiple myeloma. The main goal of the study was to measure the length of time patients lived without their multiple myeloma getting worse or their passing away from any cause. Another goal was to measure overall response rate, which is the percentage of patients who responded to treatment. Talk to your doctor about how response is measured.

Clinical trial results: DARZALEX® + Vd vs Vd alone

DARZALEX® in combination with Vd increased the time patients lived without their multiple myeloma getting worse or their passing away from any cause.

  • 61% less risk of disease progression or passing away with DARZALEX® + Vd vs Vd alone

More patients responded to DARZALEX® in combination with Vd vs Vd alone

 

DARZALEX®  studied as a monotherapy

DARZALEX®  was studied as a monotherapy in 106 patients who had received at least 3 prior medicines to treat their multiple myeloma, including a proteasome inhibitor (PI) and an immunomodulatory agent, or did not respond to a PI and an immunomodulatory agent. Patients had received a median of 5 prior lines of therapy for their multiple myeloma.

The main goal of the study was to measure overall response rate. Overall response rate is the percentage of patients who responded to treatment. Talk to your doctor about how response is measured.

Clinical trial results: DARZALEX®  as a monotherapy

When these patients were treated with DARZALEX®, 29% responded.

  • This response lasted for a median duration of 7.4 months

Of patients who responded, response was seen between 0.9 and 5.6 months

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

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