• Although Darzalex cannot cure multiple myeloma it can improve the quality and length of life in most people.
• Unfortunately, there is currently no cure for multiple myeloma. However, the cancer can be managed successfully in many patients for years.
• Darzalex is a monoclonal antibody. It may also be called a targeted treatment. Darzalex works by binding to a specific protein called CD38 on the surface of multiple myeloma cells, causing cell death.

Darzalex (daratumumab) is a targeted treatment that may be used to treat adult patients with multiple myeloma (bone marrow cancer). It works by blocking a specific protein called CD38 on stem cells causing cell death and reducing the numbers of other cells. It also helps your immune system identify and destroy multiple myeloma cells.

How effective is Darzalex?

Darzalex is considered an effective treatment for patients with multiple myeloma (MM) and demonstrates rapid and long-lasting responses, extending a person with MM's life expectancy. Trials report:

• The addition of Darzalex to regimens containing other agents (for example Revlimid/dexamethasone) was associated with a 44% reduction in the risk of disease progression or death
• A 50% reduction in the risk of disease progression or death was reported when Darzalex was added to other agents in patients aged older than 65 years who were unable to undergo a stem cell transplant
• Adding Darzalex to Kyprolis and dexamethasone improved response rates from 75% to 84% and the rate of minimal residual disease was nearly 10-times higher in the three drugs group compared with the two-drug group
• In the Pollux study, 91% of patients treated with Darzalex in combination with lenalidomide and dexamethasone responded compared with 75% treated with lenalidomide/dexamethasone alone
• 90.9% of patients who relapsed following a stem cell transplantation were still alive one year following the start of Darzalex treatment.

How does Darzalex work?

A protein called CD38 exists on the surface of hematopoietic cells – these are the stem cells that give rise to other blood cells. CD38 has multiple functions, such as cell binding (including during inflammation), cell signaling, and regulating enzyme activity.

Darzalex binds strongly and specifically to CD38, and once bound induces an immune response that results in the death of myeloid cancer cells. Darzalex also reduces the numbers of myeloid-derived suppressor cells – these are immune cells that originate from bone marrow stem cells whose numbers are significantly increased during chronic infections and cancer, as a result of hematopoiesis (the formation of a range of different blood cells from bone marrow stem cells).

Antibodies are proteins that are used by the immune system to protect our body against foreign invaders, such as bacteria and viruses. They can be classified into five main subtypes IgA, IgD, IgE, IgG, and IgM based on the sequence and structure.

Darzalex is an IgG monoclonal antibody.

How is Darzalex given?

There are two types of Darzalex: Darzalex (daratumumab) and Darzalex Faspro (daratumumab and hyaluronidase). Darzalex is administered by infusion directly into a vein and Darzalex Faspro is given as a subcutaneous (SC) injection under the skin. Other medications, such as corticosteroids, antipyretics, and antihistamines are given before and after the infusion to help prevent serious side effects or an allergic reaction.

Darzalex has to be given more slowly than Darzalex Faspro. The first infusion of Darzalex needs to be given slowly (over approximately 7 to 8 hours) because there is a risk of allergic reactions associated with Darzalex IV. The risk of reactions decreases with subsequent infusions which can be given over about 4 hours for the second infusion and 3 hours for subsequent infusions. Darzalex Faspro is given subcutaneously over approximately 3–5 minutes.

How often Darzalex or Darzalex Faspro is given depends upon what other treatments it is used with or what you have already received.