Introduction

Daratumumab (trade name: Darzalex) has been approved in Germany since May 2016 for the treatment of multiple myeloma. The medication is a treatment option for two different groups:

  • Adults who have been treated at least once. In this group of people, daratumumab is either combined with lenalidomide and dexamethasone or with bortezomib and dexamethasone.
  • Adults who have had a recurrence of multiple myeloma and whose disease is difficult to treat. Daratumumab is an option for these people if they have already been treated with a proteasome inhibitor and an immunomodulatory drug, and their last treatment wasn't effective enough.

As of September 2018, daratumumab can also be used as first-line treatment in adults with newly diagnosed myeloma for whom a stem cell transplantation is not an option. Daratumumab is then combined with bortezomib, melphalan and prednisone.

Multiple myeloma is a rare type of cancer in which mutated plasma cells belonging to the immune system multiply uncontrollably in the bone marrow. If the disease progresses, it destroys bone tissue and prevents normal blood formation. This can cause bone pain and bone fractures, as well as anemia. Multiple myeloma is a life-threatening condition.

It is divided into different stages according to the International Staging System (ISS). This categorization is mainly based on the amount of two proteins in the blood. There are three different stages: mild (ISS 1), moderate (ISS 2) and severe (ISS 3).

Daratumumab binds to cancer cells in order to destroy them. It is also supposed to stimulate the immune system to attack the cancer cells.

Application

Daratumumab is given as an infusion (drip), and the dose is based on body weight. The number of infusions and the time intervals between infusions depend on factors such as previous treatments and the exact diagnosis.

Other treatments

The first-line treatment options for adults with newly diagnosed myeloma are thalidomide or bortezomib in combination with melphalan and prednisone. Lenalidomide combined with dexamethasone can also be used.

Patients who have already been treated at least once can use the medication bortezomib combined with doxorubicin or dexamethasone. Other options include lenalidomide in combination with dexamethasone, or elotuzumab in combination with lenalidomide and dexamethasone.

If multiple myeloma comes back after previous treatments, optimized individual therapy is the standard treatment option. The exact type of therapy will depend on several things, such as which treatments have been tried before, and is adapted individually by a doctor.

Assessment

In 2018, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of daratumumab compared with the standard treatments for people with multiple myeloma.

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More information

This information summarizes the main results of reviews produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The reviews were commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the reviews and the hearings received, the G-BA passed a resolution on the added benefit of daratumumab (Darzalex).