Darzalex® (daratumumab) Combination Approved for Adults with Relapsed or Refractory Multiple Myeloma

Last updated: November 2020

The U.S. Food and Drug Administration (FDA) has approved Darzalex® (daratumumab) in combination with carfilzomib and dexamethasone. The approved combination of drugs, known as DKd, is for adults living with relapsed/refractory multiple myeloma who have already had 1 to 3 previous lines of treatment.1

Darzalex is the first CD38 antibody approved for use with carfilzomib. This is the 8th U.S. approval for darzalex and the 5th for relapsed/refractory multiple myeloma.1

This approval adds another treatment option for those with relapsed/refractory multiple myeloma for whom other treatments have not been effective.

How does Darzalex work?

Darzalex is a type of monoclonal antibody therapy. This means it is a type of immunotherapy. It works by sticking to CD38 on the outside of multiple myeloma cells. CD38 is a protein that is found on the outside of multiple myeloma cells. Darzalex works by stopping the growth of these cells and/or helping the immune system destroy these cells. This may help slow the spread of multiple myeloma.2

Evidence for the the DKd combination

The approval of Darzalex in combination with carfilzomib and dexamethasone was based on results from a phase 3 clinical trial and a phase 1b clinical trial.1,2

The phase 3 trial included 466 people with relapsed or refractory multiple myeloma who relapsed after 1 to 3 previous therapies. The participants received either DKd or carfilzomib and dexamethasone alone. Those who received DKd experienced a 37 percent reduction in the spread of their disease.1,2

The phase 1b study included 103 people with multiple myeloma who had previously received treatment with a proteasome inhibitor and an immunomodulatory agent. The study evaluated the safety, tolerability, and dose regimen of the DKd combination. The overall response rate (the percent of people who respond to the drug) was 59 percent.1,2

What are the side effects of the DKd combination?

Common side effects of Darzalex in combination with carfilzomib and dexamethasone include:2

  • Blood and lymphatic system disorders (lowered platelet count, lowered white blood cell count)
  • Fatigue
  • Infusion-related reactions
  • Fever

The most frequent severe side effects include:2

  • Pneumonia
  • Upper respiratory tract infection
  • Basal cell carcinoma
  • Influenza
  • General physical health deterioration

Infusion-related reactions occurred in about 44 percent of those taking the combination.2

These are not all the possible side effects of Darzalex in combination with carfilzomib and dexamethasone. Talk to your doctor about what to expect or if you experience any changes that worry you.

Things to know about Darzalex

If you have ever had or currently have a hepatitis B infection, Darzalex can cause the virus to become active again. Your doctor should check you for signs of infection before, during, and after treatment with Darzalex. Tell your doctor if you experience fatigue or yellowing of the skin or eyes while taking Darzalex.

It is not known if Darzalex is safe and effective for children.2

Darzalex may be harmful to a developing baby. Women of childbearing age should use effective birth control during treatment with Darzalex and for at least 3 months after the final dose. Prior to using this drug, tell your doctor if you are pregnant or plan to become pregnant. It is not known whether this drug is safe to take while breastfeeding.2

Tell your doctor about any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.

For more information, read the full prescribing information of Darzalex.

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