Expanded Approval for Darzalex – Newly Diagnosed, Transplant-Ineligible Multiple Myeloma

The U.S. Food and Drug Administration (FDA) has recently expanded the usage of Darzalex® (daratumumab): it is now approved to be used in combination with Velcade® (bortezomib), melphalan, and prednisone (a combination known as VMP) in people with newly diagnosed multiple myeloma who are not eligible for an autologous stem cell transplant. Prior to this expanded approval, Darzalex was only approved to be used as a monotherapy or in combination with other medications in people with multiple myeloma who had already received prior therapies.1,2

What is Darzalex?

Darzalex is a monoclonal antibody that targets the CD38 protein, which is present in high numbers on multiple myeloma cells. The CD38 protein is also present on certain other cells, like red blood cells. When Darzalex attaches to this protein, it can directly kill the cancer cell or alerts the immune system to kill the cancer cells.3

Darzalex is given as an intravenous (IV) infusion, and the dosage is based on the body weight of the patient.2

What research has been done on Darzalex in newly diagnosed multiple myeloma?

The FDA considered data from a recent clinical trial that included 706 people with newly diagnosed multiple myeloma who were ineligible for stem cell transplant. The patients were randomly assigned to receive either the chemotherapy VMP or VMP plus Darzalex. Study results demonstrated that those who received Darzalex in addition to the VMP chemotherapy had a 50% reduction in the risk of disease progression or death. The addition of Darzalex also improved overall response rates – 91% of those receiving Darzalex had a response to treatment versus 74% of those who received just VMP.1

What are the possible side effects of Darzalex?

The most common side effects experienced by patients taking Darzalex in combination with VMP are upper respiratory tract infection (experienced by 48% of patients), reactions to the infusion (experienced by 28%), and swelling of the arms and legs (experienced by 21%). Infusion reactions may include difficulty breathing, low blood pressure (hypotension) which may cause dizziness or lightheadedness, coughing, wheezing, headache, itching, nausea, vomiting, chills, or fever. Darzalex may cause serious side effects, including pneumonia, excess fluid in the lungs (pulmonary edema), or lowered blood cell counts.1,3

What else should I know about Darzalex?

Women who are able to become pregnant should use an effective method of birth control during treatment and for at least three months following treatment, as Darzalex may harm an unborn child.2

It is not known whether Darzalex can be passed through breastmilk, so women who are breastfeeding should talk to their doctor about the risks and benefits of using Darzalex.2

Before starting treatment with Darzalex, patients should talk to their doctor about all their health conditions, especially if they have a history of breathing problems, have had shingles (herpes zoster), are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed.2

Before starting treatment with Darzalex, patients should talk to their doctor about all medications, vitamins, and supplements they are taking, as some may have negative interactions with each other.2

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